(copy) daveV-1 $RLFTF related - - Features of Fast Track Designation
1. Actions to Expedite Development and Review There are opportunities for frequent interactions with the review team for a fast track product. These include meetings with FDA, including pre-IND meetings, end-of-phase 1 meetings, and end-of-phase 2 meetings to discuss study design, extent of safety data required to support approval, dose-response concerns, and use of biomarkers. Other meetings may be scheduled as appropriate (e.g., to discuss accelerated approval, the structure and content of an NDA, and other critical issues). In addition, such a product could be eligible for priority review if supported by clinical data at the time of BLA, NDA, or efficacy supplement submission
2. Submission of Portions of an Application (Rolling Review) If FDA determines, after preliminary evaluation of clinical data submitted by a sponsor, that a fast track product may be effective, the Agency may consider reviewing portions of a marketing application before the sponsor submits the complete application
Source starts on pg 6: https://www.fda.gov/media/86377/download
I have only seen Fast Track Designation benefits from the BLA rolling review in the biologics I have invested in, That said most companies don't disclose details of meeting logistics that are some of the other possible benefits. There is nothing mentioned about EUA specifically however I assume the open communications channel would leave that door open.
I am optimistic that Aviptadil is granted EUA as soon as the trial enrollment is completed. The demand for help treating folks with COVID lung infections is overwhelming at this point.
1. Actions to Expedite Development and Review There are opportunities for frequent interactions with the review team for a fast track product. These include meetings with FDA, including pre-IND meetings, end-of-phase 1 meetings, and end-of-phase 2 meetings to discuss study design, extent of safety data required to support approval, dose-response concerns, and use of biomarkers. Other meetings may be scheduled as appropriate (e.g., to discuss accelerated approval, the structure and content of an NDA, and other critical issues). In addition, such a product could be eligible for priority review if supported by clinical data at the time of BLA, NDA, or efficacy supplement submission
2. Submission of Portions of an Application (Rolling Review) If FDA determines, after preliminary evaluation of clinical data submitted by a sponsor, that a fast track product may be effective, the Agency may consider reviewing portions of a marketing application before the sponsor submits the complete application
Source starts on pg 6: https://www.fda.gov/media/86377/download
I have only seen Fast Track Designation benefits from the BLA rolling review in the biologics I have invested in, That said most companies don't disclose details of meeting logistics that are some of the other possible benefits. There is nothing mentioned about EUA specifically however I assume the open communications channel would leave that door open.
I am optimistic that Aviptadil is granted EUA as soon as the trial enrollment is completed. The demand for help treating folks with COVID lung infections is overwhelming at this point.
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