FDA RFA-FD-25-020: Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01)
The Short Answer
RFA-FD-25-020 is an FDA grant that pays for rare disease clinical trials. It provides up to $650,000 in total costs per year for up to four years, and up to $900,000 per year if you use an innovative or efficient trial design. The money is non-dilutive, meaning you give up no equity and no intellectual property. Applications are due October 20, 2026 and October 19, 2027, and the opportunity expires May 31, 2028.
The program is run by the FDA Office of Orphan Products Development (OOPD), not by the NIH, even though you apply through Grants.gov and eRA Commons. FDA uses its own Objective Review Process, its own page limits, and its own review criteria.
Small businesses and for-profit companies are explicitly eligible, and companies win these awards regularly. More on that below.
RFA-FD-25-020 At A Glance
Funding opportunity number: RFA-FD-25-020
Title: Reissue of RFA-FD-23-001, Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Agency: U.S. Food and Drug Administration, Office of Orphan Products Development (OOPD)
Activity code: R01 Research Project Grant
Assistance Listing Number: 93.103
Clinical trial status: Required. FDA will only accept applications proposing clinical trials.
Award ceiling, standard: $650,000 total costs per year, years 1 through 4
Award ceiling with innovative design justification: $900,000 total costs per year, years 1 through 4
Maximum project period: 4 years
Maximum possible total award: $3,600,000
Cost sharing or matching: Not required
Application types allowed: New, Renewal, Resubmission, Revision
Next application deadline: October 20, 2026, by 11:59 PM Eastern Time
Final application deadline: October 19, 2027, by 11:59 PM Eastern Time
Resubmission-only deadlines: May 18, 2027 and May 16, 2028
Opportunity expiration date: May 31, 2028
Late applications: Not accepted under any circumstances
Appeals of review outcome: Not accepted
Foreign organizations: Eligible
Why Startups and Small Companies Should Pay Attention
The R01 label makes founders assume this is an academic-only program. It is not, and the award history proves it.
Under the immediately preceding version of this opportunity, RFA-FD-23-001, FDA funded roughly twenty distinct clinical trial projects. Four of those projects went to for-profit companies rather than universities or hospitals. Based on NIH RePORTER records, those company awards include:
Ophirex, Inc. (California). Development of intravenous varespladib, a phospholipase A2 inhibitor, for snakebite envenoming. Approximately $2.89 million in cumulative reported funding across fiscal years 2023 through 2025.
Extend Biosciences, Inc. (Massachusetts). A Phase 2 study of EXT608 in adults with hypoparathyroidism, conducted under IND 146180. Approximately $1.8 million in cumulative reported funding, with annual budgets of roughly $899,800, effectively at the top of the funding ceiling.
Palvella Therapeutics, Inc. (Pennsylvania). SELVA, a multicenter Phase 3 baseline-controlled study of PTX-022 in microcystic lymphatic malformations. Approximately $1.13 million in cumulative reported funding across fiscal years 2024 and 2025.
Targeted Therapy Technologies, LLC (New Jersey). A Phase II expanded access clinical trial in retinoblastoma. $1.3 million in cumulative reported funding across fiscal years 2024 and 2026.
Together, those four companies pulled in roughly $7.1 million from a single issue of this opportunity. That is close to one in five funded projects going to industry.
This is not new behavior at OOPD either. Under earlier issues of the same program, DNAtrix, Inc. won multi-year support for a Phase 2a study of DNX-2401 in glioblastoma, and Fibrocell Technologies, Inc. won multi-year support for a Phase 1/2 study of FCX-007 in recessive dystrophic epidermolysis bullosa. Companies have been winning orphan products clinical trials grants for a decade.
Three additional reasons this program fits a clinical-stage company unusually well:
None of the SBIR eligibility constraints apply. There is no 500-employee size standard, no requirement that the principal investigator be primarily employed by your company, no 51 percent United States ownership test, and no Phase I before Phase II sequencing. If your company can run the trial, you can apply.
Indirect costs are available even without a negotiated rate. If your organization has never established a federal indirect cost rate, FDA allows a de minimis rate of 10 percent of modified total direct costs. Most early-stage companies have no negotiated rate, and most assume that means zero overhead recovery.
The award is a regulatory asset, not just cash. OOPD holds regulatory milestone meetings with awardees and monitors progress toward approval. An FDA office is actively invested in your product reaching the market.
What FDA Is Actually Looking For
The purpose of RFA-FD-25-020 is to fund clinical trials that evaluate safety and efficacy in support of a new indication or a change in labeling for a product treating a rare disease or condition. That phrase is the center of gravity of the entire program. FDA is not funding discovery science, target validation, mechanism studies, or device engineering. FDA is funding the human trial data that moves a product closer to an approved label.
The problem FDA is trying to solve
There are more than 10,000 known rare diseases affecting roughly 30 million Americans, and only a few hundred of those diseases have approved treatments. The Orphan Products Grants Program has funded clinical trial research since 1983, and more than 80 of the studies it has funded have gone on to facilitate marketing approval of a rare disease product. That is the outcome FDA is buying with this money.
What is in scope
Clinical trials in any phase of development, meaning Phase 1, Phase 2, and Phase 3 are all eligible
Drugs, biologics, medical devices, and medical foods
Studies of already approved products being evaluated for a new orphan indication
Studies assessing multiple rare diseases at once, provided prevalence data is supplied for each disease
Diagnostics and vaccines, but only where the United States population receiving them is fewer than 200,000 people per year
What FDA specifically rewards
Read the announcement closely and four preferences show up over and over. Applications that hit these read as responsive. Applications that ignore them read as academic proposals that wandered into the wrong program.
1. Efficient use of existing infrastructure. FDA wants you to plug into clinical trial networks, data standardization platforms, patient registries, electronic medical records, and CTSAs rather than building everything from scratch. Show that you are not reinventing infrastructure that already exists.
2. Genuine collaboration across stakeholders. FDA repeatedly names the combination of industry, academia, and patient organizations. A company applicant partnered with academic trial sites and a disease foundation is the archetype this program was written for.
3. Early and ongoing patient engagement. This is a scored review criterion in its own right, not a box to check. FDA wants documented evidence that patients and caregivers shaped the protocol design, the data elements, the feasibility assessment, and the data sharing approach. You also need to show how you reduced patient and caregiver burden, including impact on daily living. Letters from patients, caregivers, or patient organizations describing that engagement are required.
4. Innovative and efficient trial designs. This is where the extra $250,000 per year lives. FDA will consider additional funding for applications proposing seamless or adaptive designs that compress trial phases into one continuous trial, basket trials, umbrella trials, or platform trials that test multiple drugs or multiple diseases on common infrastructure. FDA will also consider it for innovative use of data modeling and simulation to study safety and efficacy. FDA strongly recommends engaging a review division about these approaches before you submit, through a preIND meeting, an INTERACT meeting, or another mechanism.
The rare disease definition you must document
FDA considers a product potentially eligible if it is indicated for a disease or condition with a prevalence of fewer than 200,000 people in the United States. For acute diseases lasting less than one year, the annual incidence must be fewer than 200,000 per year. You must document this in a dedicated subsection of your Rationale, using the exact heading "Rare Disease Population/Prevalence," with prevalence calculations and citations.
Orphan subsets of a non-rare disease can qualify, but only if you can explain, based on a characteristic of the product such as mechanism of action, toxicity profile, or prior clinical experience, why the product would be limited to that subset. An orphan subset argument cannot be based on unmet need alone or on how you would prefer to study or market the product. If you already hold OOPD orphan drug designation for the product and disease, include the designation number and date.
Funding Allowance in Detail
Annual budget caps
Year 1: $650,000 total costs
Year 2: $650,000 total costs
Year 3: $650,000 total costs
Year 4: $650,000 total costs
Standard four-year maximum: $2,600,000 total costs
These are total costs, meaning direct plus indirect combined. This is the single most misread line in the announcement. Applicants who budget $650,000 in direct costs and then add overhead on top are over budget before review begins.
The innovation supplement
Applications proposing qualifying innovative and efficient trial approaches may request up to an additional $250,000 in total costs per year, raising the ceiling to $900,000 total costs per year for up to four years, or $3,600,000 across the full project period.
To access it you must submit a clear description and justification, limited to three pages, showing how you meet the innovative design requirements. That justification goes in the appendix, and the request must also be reflected in the budget request. FDA reviews the additional funding annually. Applications that request the supplement without meeting the requirements may be asked to reduce their budget.
Indirect costs
If you request indirect costs, you must attach a copy of your most recent federal indirect cost rate or F&A agreement to the Research and Related Other Project Information component as line 12, Other Attachments.
If you have never established an indirect cost rate and have no negotiated federal agreement, a de minimis rate of 10 percent of modified total direct costs is allowed. Modified total direct costs include direct salaries and wages, applicable fringe, materials and supplies, services, travel, and the first $25,000 of each subaward. It excludes equipment, capital expenditures, patient care charges, rental costs, tuition remission, scholarships, participant support costs, and any portion of a subaward above $25,000.
Foreign and international organizations are funded at a fixed 8 percent of modified total direct costs.
Other budget rules
Cost sharing is not required.
Applications requesting multiple years must submit a separate detailed budget and narrative justification for each year.
You must disclose other funds contributed to the study by any source, including your own company, both before and during the FDA funding period. Provide amounts, sources, and whether the funds are secured. Keep this separate from the FDA request justification.
No award funds may pay any individual at a salary rate above Executive Level II of the Federal Executive Pay Scale.
Awards provide one year of support with three additional recommended years contingent on annual appropriations, availability of funds, and satisfactory performance. Continuation also depends on enrollment progress, adequate product supply, and compliance with IND or IDE regulatory requirements.
Timeline and Key Dates
Recurring annual cycle
Optional Letter of Intent: September 21, 2026, then September 20, 2027
New application due dates: October 20, 2026, then October 19, 2027, both by 11:59 PM Eastern Time
Resubmission-only due dates: May 18, 2027, then May 16, 2028
Scientific merit review, new applications: February and March of 2027 and 2028
Scientific merit review, resubmissions: June of 2027 and 2028
Earliest project start date: July 2026 for the first cycle, with later cycles following the same pattern
Opportunity expiration: May 31, 2028
The deadline before the deadline
The date that actually controls your timeline is not the application due date. It is the IND or IDE submission date.
Your protocol and all other required regulatory documents must be submitted to the applicable FDA IND or IDE review division a minimum of 30 days before the grant application deadline. For the October 20, 2026 cycle, that means the protocol needs to be with the review division on or before September 20, 2026.
The IND must be active, meaning not on clinical hold and not exempted, or the IDE must be approved, for your grant application to qualify for review. Miss this and the application is non-responsive regardless of scientific merit.
A realistic backward-planning schedule for an October cycle
6 to 8 months out: Request a preIND or INTERACT meeting if you plan to propose an innovative trial design, or if your regulatory path is unsettled.
4 to 6 months out: Confirm SAM.gov, UEI, eRA Commons, and Grants.gov registrations. Registration can take six weeks or longer, and failure to register in time is not an accepted excuse for late submission. Principal investigator eRA Commons accounts alone can take two weeks.
3 to 4 months out: Finalize the protocol, lock clinical sites, and begin collecting the three required categories of letters of support.
30 days plus before the deadline: Submit the final protocol to your IND or IDE. The version you submit to FDA in the grant application must be the same version submitted to the IND or IDE.
3 to 4 weeks out: Complete the Research Strategy, the innovation supplement justification if applicable, and the Data Management and Sharing Plan.
1 week out: Submit. Grants.gov and eRA Commons both run error checks, and any errors must be corrected and a changed or corrected application submitted before the deadline. A corrected application filed after the deadline is late, and late applications are not accepted.
Registration checklist
System for Award Management (SAM) registration, active and renewed at least annually, which generates your Unique Entity Identifier and a CAGE code. Foreign organizations need an NCAGE code instead.
eRA Commons accounts with at least one Signing Official and at least one Program Director or Principal Investigator. If the same person is both PI and Signing Official, they need two distinct accounts.
Grants.gov registration, which requires active SAM registration first.
Who Is Eligible
Eligible organizations include:
Public, state controlled, and private institutions of higher education
Nonprofits with and without 501(c)(3) status
Small businesses
For-profit organizations other than small businesses
State, county, city, township, and special district governments
Federally recognized and non-federally recognized tribal governments and Native American tribal organizations
Federal governments and United States territories or possessions
Independent school districts, public housing authorities, faith-based and community-based organizations, and regional organizations
Non-domestic, non-United States entities, and non-domestic components of United States organizations
Principal investigator requirements:
Any individual with the skills, knowledge, and resources to carry out the research may serve as PD/PI.
FDA expects an established investigator in the relevant scientific area who can provide both administrative and scientific leadership.
Every PD/PI must hold an eRA Commons account, and the Commons ID must appear in the Credential field of the Senior/Key Person Profile. Omitting it causes the application to be rejected.
Multiple PDs/PIs are allowed. One must be designated the Contact PI in item 14 of the SF424 (R&R). Multi-PI applications must include a Multiple PD/PI Leadership Plan covering governance, communication, decision-making on scientific direction, and conflict resolution.
With multiple institutions, one must be the prime and all others must be funded through subcontracts, with their budgets attached to the Research and Related Subaward Budget Attachment form.
You may submit more than one application, provided each is scientifically distinct. FDA will not accept duplicate or highly overlapping applications under review at the same time.
Application Structure and Required Content
Page limits
FDA does not follow NIH page limitation guidelines or NIH review criteria. For this NOFO, the Research Strategy is limited to 12 pages. A resubmission adds a one-page Introduction addressing the prior Summary Statement.
Required Research Strategy sections
Your Research Strategy must contain these five sections, in this order, because they map directly onto the scored review criteria:
Rationale
Study Design including Data Quality and Interpretability
Inclusion of Patient Input
Investigator(s), Infrastructure, and Financial Resources
Ability to Advance the Current Field
Required subsections with mandated headings
Three subsections must appear under specific headings. Reviewers look for these headings literally.
Under Rationale: "Rare Disease Population/Prevalence", documenting that the United States prevalence or incidence meets the rare disease threshold, with calculations and citations.
Under Rationale: "Support of Product Development", explaining how the study will help support product approval or supply essential data for product development. If you propose multiple products or multiple diseases, describe how you intend to proceed with development, potentially across multiple sponsors.
Under Study Design: "Study Monitoring Plan", describing your monitoring approach, whether a Data and Safety Monitoring Board, a Study Monitoring Committee, or an Independent Medical Monitor. Name the parties responsible, what will be monitored, the frequency, and the individual and study stopping guidelines.
Required letters of support
Letters of support do not go in the Research Strategy. They are uploaded to line 9 of the PHS 398 Research Plan form. Three categories are required:
Study sites. Leaders of the clinical research institutions conducting the study describe site support, resources, study infrastructure, and an estimate of how many patients with the target disease would be eligible.
Product availability. Evidence that the product is available to you in the form and quantity the trial needs. A current supplier letter is acceptable. If supply negotiations are underway but not final, submit a letter saying so. Verification of adequate supply is required before an award is made.
Patient engagement. Current letters from patients, caregivers, or patient organizations describing early and ongoing engagement in trial design.
Required appendices
The full final protocol, specifically the version submitted to the IND or IDE
Informed consent forms, assent forms, and any other information given to subjects, compliant with 21 CFR 50.25
The innovative and efficient trial approach justification, limited to three pages, if you are requesting additional funding
For resubmissions, the previous OOPD Summary Statement, with an optional point-by-point rebuttal
Do not use the appendix to get around page limits.
Other required elements
A Data Management and Sharing Plan is required for all applications regardless of direct cost level, attached in the Other Plan(s) slot.
At least one human subjects study record using the PHS Human Subjects and Clinical Trials Information form.
The IND or IDE number and the date the final protocol version was submitted must appear with the project title on the face page of the application.
If the IND or IDE sponsor is not the listed principal investigator, a letter from the sponsor permitting access to the IND or IDE must be submitted both in the IND or IDE and in the grant application.
How Applications Are Reviewed
Review happens in two stages.
Stage one, responsiveness screening. FDA grants management and program staff review every application against nine program responsiveness criteria. Applications found non-responsive receive notice that they will not be reviewed at all. The criteria include proposing a clinical trial that provides safety or efficacy data for a rare disease, using the generic name of the product, requesting no more than four years, documenting rare disease prevalence, explaining how the trial supports a new indication or labeling change, meeting the IND and IDE requirements under 21 CFR 312 for drugs and biologics or 21 CFR 812 for devices, providing the required appendices and letters, and complying with page and formatting limits.
Only medical foods that do not require premarket approval and devices classified as non-significant risk are exempt from the IND and IDE requirement. Non-significant risk device applicants must include a letter from the FDA Center for Devices and Radiological Health confirming the classification.
Stage two, objective review. Responsive applications go to an FDA Objective Review Committee of subject matter experts, which assigns an overall impact score reflecting the likelihood the project will exert a sustained and powerful influence on the field. FDA experts may be consulted on whether the study will generate data that could contribute to product approval. Funding decisions are made by the Commissioner of Food and Drugs or a designee, based on scientific and technical merit, availability of funds, and relevance to program priorities.
Every application receives a written critique. Appeals of objective review are not accepted for this NOFO.
Note that reviewers are told an application does not need to be strong in every category, and that a project which is not innovative in itself may still be essential to advance a field. The relative importance of strengths and weaknesses matters more than the count.
Additional items reviewers assess without separate scores
Study timeline, including start-up activities, enrollment rate, follow-up, use of existing resources for efficiency, and contingency plans for enrollment shortfalls
Protections for human subjects, across risk, adequacy of protection, potential benefits, importance of knowledge gained, and data and safety monitoring
Biohazards
Resource sharing plans
Authentication of key biological and chemical resources
Whether the budget and requested period of support are fully justified and reasonable
Common Reasons Good Science Loses This Grant
The protocol was not submitted to the IND or IDE division at least 30 days before the deadline, or the IND is on clinical hold or exempted.
The version of the protocol in the grant application does not match the version submitted to the IND or IDE.
Budget built as $650,000 in direct costs, with indirect costs stacked on top, blowing the total cost cap.
Prevalence documented in prose without the mandated "Rare Disease Population/Prevalence" heading, or without calculations and citations.
Patient engagement described as an intention rather than evidenced with letters from patients, caregivers, or patient organizations.
No letter confirming product availability in the form and quantity the trial requires.
The innovation supplement requested without a three-page appendix justification meeting the stated design requirements.
SAM, eRA Commons, or Grants.gov registration incomplete at the deadline, which is never an accepted reason for a late submission.
Missing eRA Commons ID in the Credential field of the Senior/Key Person Profile, which causes outright rejection.
Submitting close to the deadline, hitting Grants.gov or eRA Commons errors, and correcting them after 11:59 PM Eastern. Late is late.
Frequently Asked Questions
What is RFA-FD-25-020?
RFA-FD-25-020 is a Notice of Funding Opportunity from the FDA Office of Orphan Products Development that funds clinical trials of orphan products in support of a new indication or a change in labeling for a rare disease or condition. It is a reissue of RFA-FD-23-001 and uses the R01 activity code.
How much money can I get from RFA-FD-25-020?
Up to $650,000 in total costs per year for up to four years, which is $2.6 million maximum. If you propose a qualifying innovative or efficient trial design and justify it in a three-page appendix, you may request up to an additional $250,000 per year, raising the ceiling to $900,000 per year and $3.6 million across four years. All figures are total costs, meaning direct plus indirect combined.
When are RFA-FD-25-020 applications due?
New applications are due October 20, 2026 and October 19, 2027, both by 11:59 PM Eastern Time. Resubmission-only deadlines are May 18, 2027 and May 16, 2028. Optional letters of intent are requested by September 21, 2026 and September 20, 2027. The opportunity expires May 31, 2028. Late applications are not accepted.
Can a small business or startup apply for RFA-FD-25-020?
Yes. Small businesses and for-profit organizations are explicitly listed as eligible applicants. Under the previous issue of this opportunity, RFA-FD-23-001, roughly one in five funded projects went to for-profit companies, including Ophirex, Extend Biosciences, Palvella Therapeutics, and Targeted Therapy Technologies. Earlier issues funded companies including DNAtrix and Fibrocell Technologies.
Is RFA-FD-25-020 an SBIR grant?
No. This is an R01 research project grant, not an SBIR or STTR award. That means none of the SBIR eligibility restrictions apply. There is no small business size standard, no requirement that the principal investigator be primarily employed by the applicant company, no United States ownership percentage test, and no Phase I prerequisite. Companies of any size may apply.
Do I need an active IND or IDE to apply?
In almost all cases, yes. The protocol and all other required documents must be submitted to the applicable FDA IND or IDE review division at least 30 days before the grant application deadline. The IND must be active, meaning not on clinical hold and not exempted, or the IDE must be approved, for the application to qualify for review. The only exceptions are medical foods that do not require premarket approval and medical devices classified as non-significant risk, which need a letter from the Center for Devices and Radiological Health confirming the classification.
What counts as a rare disease for this grant?
For chronic diseases, a prevalence of fewer than 200,000 people in the United States. For acute diseases lasting less than one year, an annual incidence of fewer than 200,000 per year. Diagnostics and vaccines qualify only if the United States population receiving them is fewer than 200,000 people per year. Orphan subsets of non-rare diseases may qualify if a product characteristic such as mechanism of action or toxicity profile justifies limiting use to that subset.
Which clinical trial phases are eligible?
All of them. RFA-FD-25-020 supports clinical trials in Phase 1, Phase 2, and Phase 3 of product development, as long as the trial evaluates safety or efficacy in support of a new indication or a change in labeling.
What kinds of products are eligible?
Drugs, biologics, medical devices, and medical foods indicated for rare diseases or conditions. Already approved products being studied for a new orphan indication are eligible. Diagnostics and vaccines are eligible under the population limits described above.
What are the innovative trial designs that unlock extra funding?
Seamless and adaptive designs that compress trial phases into one continuous trial, plus basket, umbrella, and platform trials that test multiple drugs or multiple diseases on shared infrastructure. Innovative use of data simulation and modeling to study safety and efficacy also qualifies. FDA strongly recommends discussing these approaches with the relevant review division before applying, through a preIND or INTERACT meeting.
Is cost sharing or matching required?
No. RFA-FD-25-020 does not require cost sharing. You must still disclose other funds contributed to the study from any source, including your own company, with amounts, sources, and whether the funds are secured.
Can I get indirect costs if my company has no negotiated federal rate?
Yes. If your organization has never established an indirect cost rate and has no negotiated federal agreement, FDA allows a de minimis rate of 10 percent of modified total direct costs. If you do have a negotiated rate, attach the agreement to the Research and Related Other Project Information component as line 12, Other Attachments. Foreign organizations are funded at a fixed 8 percent.
How long is the Research Strategy?
Twelve pages for this NOFO. FDA does not follow NIH page limitation guidelines. Resubmissions add a one-page Introduction addressing the prior Summary Statement.
Can foreign organizations apply?
Yes. Non-domestic, non-United States entities are eligible, as are non-domestic components of United States organizations. Foreign components are allowed. Indirect costs for foreign and international organizations are capped at 8 percent of modified total direct costs.
Can I submit more than one application?
Yes, provided each application is scientifically distinct. FDA will not accept duplicate or highly overlapping applications under review at the same time, and will not accept a new application submitted before the summary statement issues from an overlapping prior application.
Can I appeal if my application is not funded?
No. Appeals of objective review are not accepted for applications submitted under this NOFO. The decision not to award, or to award at a particular funding level, is discretionary and not subject to appeal. You may, however, submit a resubmission application at a resubmission-only deadline, provided your prior application received a numeric score and does not require an IND protocol amendment before resubmission.
Is this funding dilutive?
No. This is a federal grant, not an investment. You give up no equity, no board seats, and no intellectual property rights. It is non-dilutive capital that also puts an FDA office in the position of tracking your product toward approval.
How is FDA review different from NIH review?
FDA uses its own Objective Review Process rather than NIH peer review, applies its own page limits rather than NIH page limitation guidelines, and applies its own review criteria. Applications are still submitted through Grants.gov and tracked in eRA Commons, and FDA still applies HHS grants policy, which is why the announcement reads like an NIH opportunity in places. When FDA program-specific instructions conflict with the general application guide, follow the FDA instructions.
Who do I contact at FDA about this opportunity?
Scientific and programmatic questions go to Katherine Needleman, Director of the Orphan Products Grants Program at OOPD, at katherine.needleman@fda.hhs.gov or 301-796-8660. Letters of intent go to OOPD_CTGrants@fda.hhs.gov. Peer review and grants management questions go to Patrick Johnson at the FDA Office of Acquisitions and Grants Services, at Patrick.Johnson@fda.hhs.gov. FDA encourages applicants to resolve responsiveness questions before submitting.
What To Do Next
If you have a rare disease product with a protocol at or near IND or IDE stage, the October cycle is winnable and the competition is smaller than founders assume. The gating item is regulatory, not scientific: the protocol has to be with the FDA review division 30 days before the application deadline.
Where most companies lose this grant is not the science. It is the responsiveness screen, the total cost math, the patient engagement evidence, and the letters of support. Those are all solvable with enough runway.
BW&CO helps deep tech, biotech, and medtech companies win non-dilutive federal funding, with more than $350 million in funding secured for clients to date. If you are evaluating RFA-FD-25-020, we can assess fit against your regulatory timeline and build the application strategy around it.
