(Total Views: 542)
Posted On: 04/25/2023 12:36:06 PM
Post# of 154730
The one thing that would be helpful, as far as i'm concerned - would be some communication from CytoDyn regarding the scope and projected timing of the company's response to the latest (BS) inquiry from the FDA - now that they've had some time to reflect on it. Clearly it was still freshly in shell-shock mode during the call.
Because, For me, I left the last call totally unclear on exactly what the tangible follow-up was - and without even a ballpark on timing. Maybe the company is still figuring that out - but to me, I'm left with uncertainty as to timing. Will it take 6 days, 6 weeks or 6 months to satisfy this new requirement of our goal / protocol within HIV?. I personally think it could take some time - but if CA would simply communicate saying "ok, this was unexpected, but we're working on this - i will take less time than the original request, and we hope to have it submitted this Summer" - or something along those lines, i would feel much better. Otherwise, it feels like a black hole to me at this point.
Because, For me, I left the last call totally unclear on exactly what the tangible follow-up was - and without even a ballpark on timing. Maybe the company is still figuring that out - but to me, I'm left with uncertainty as to timing. Will it take 6 days, 6 weeks or 6 months to satisfy this new requirement of our goal / protocol within HIV?. I personally think it could take some time - but if CA would simply communicate saying "ok, this was unexpected, but we're working on this - i will take less time than the original request, and we hope to have it submitted this Summer" - or something along those lines, i would feel much better. Otherwise, it feels like a black hole to me at this point.
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