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Posted On: 09/30/2019 5:35:15 PM
Post# of 148984
The science is already confirmed...multiple times over by now. BTD would not doing much to confirm a science that has already been proven by many.
I don't quite understand why everyone is so anxious about Breakthrough Therapy Designation. We have already submitted p1 of BLA and within months of submitting p2/3 of BLA. BTD is typically meant for pharma's to apply for before initiation of Phase 3 or at least at very beginning of clinical trials before interim data. There is little benefit for BTD at this time. If it takes up to 2 months for FDA to review our request for BTD, and it will be Oct. 1 tomorrow, and we plan on submitting for BLA by end of Nov or Dec, why would we waste time on that instead of focusing on BLA exclusively? Not to mention we had already applied for BTD 1 time for sure, and possibly a 2nd time if I remember correctly, and FDA denied us BTD for HIV combo.
If anything we should be applying for Priority Review to expedite the approval date.
I don't quite understand why everyone is so anxious about Breakthrough Therapy Designation. We have already submitted p1 of BLA and within months of submitting p2/3 of BLA. BTD is typically meant for pharma's to apply for before initiation of Phase 3 or at least at very beginning of clinical trials before interim data. There is little benefit for BTD at this time. If it takes up to 2 months for FDA to review our request for BTD, and it will be Oct. 1 tomorrow, and we plan on submitting for BLA by end of Nov or Dec, why would we waste time on that instead of focusing on BLA exclusively? Not to mention we had already applied for BTD 1 time for sure, and possibly a 2nd time if I remember correctly, and FDA denied us BTD for HIV combo.
If anything we should be applying for Priority Review to expedite the approval date.
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