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Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Cerebroprotection- Interventions from Small Businesses (U44 Clinical Trial Not Allowed)
The purpose of this funding opportunity announcement (FOA) is to invite applications for Phase II SBIR applications to test promising cerebrovascular interventions in the NINDS Stroke Preclinical Assessment Network (SPAN). SPAN will facilitate the testing of up to 8 promising cerebroprotective drugs or interventions to be given prior to or at the time of reperfusion in experimental models of ischemic stroke (e.g., transient middle cerebral artery occlusion (tMCAo)). The PIs of the awarded interventions will become part of the network and will collaborate with the SPAN Coordinating Center (RFA-NS-22-004), testing laboratories (RFA-NS-22-003), and other intervention contributors (RFA-NS-22-066, RFA-NS-22-067) to facilitate the parallel testing of multiple cerebroprotective interventions in experimental models of ischemic stroke. Applicants must propose a research project involving a promising cerebroprotective intervention, supported by rigorous and extensive preliminary data, to be tested in SPAN. If successful, this network will accelerate the identification of the most promising cerebroprotective therapies for future pivotal clinical trials and span the gap between small businesses, preclinical testing laboratories, and a pipeline to clinical testing, in a cost-and time-effective fashion.
This FOA only solicits applications for SPAN intervention research projects from small businesses. Separate FOAs are issued to solicit applications for non-small business cerebroprotective intervention research projects (RFA-NS-22-066), to become a testing laboratory (RFA-NS-22-003), and for the Coordinating Center (RFA-NS-22-004).
Letter of Intent Due Date(s): 30 days prior to application due date.
Application Due Date: July 28, 2022
RFA-NS-22-067 Expiration Date July 29, 2022
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity.
A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II or IIB support, a Phase I awardee should submit a Phase II application, and a Phase II awardee should submit a Phase IIB application, within the first six due dates following the expiration of the Phase I or II budget period, respectively.
Although multiple applications from a single PI/institution will be allowed for the SPAN intervention U44 and/or testing laboratory U01 FOAs, in order to avoid a conflict of interest, the same PI being awarded a SPAN intervention U44 or SPAN CC U24 cannot be awarded a testing laboratory U01.
Similarly, although multiple applications from different PIs at a single institution will be allowed for the SPAN intervention and/or testing laboratory U44/U01 FOAs, if an intervention is awarded to the same institution awarded as a site, a conflict management plan will need to be in place.
Application budgets are limited to $300,000 in total costs per year for 3 years. Recipients are expected to can subcontract a portion of the budget to the Coordinating Center, as needed, to contribute to testing costs.