Scott Kelly was saying that they may have all thei
Post# of 154145
(Total Views: 551)
Posted On: 08/16/2022 9:02:28 PM
Re: Evil Rabbit #127713
Scott Kelly was saying that they may have all their ducks in a row to have the meeting in September. Antonio was saying it's an all hands on deck effort and he has two project managers on it along with Chris Recknor with the CRO for pharmacovigilance & by the way, Who is this CRO? Any one know?
There are other regulatory committees and they meet weekly and see how its going, all to drop the clinical hold.
I think the meeting should happen in September maybe towards mid or late month.
So all this work towards lifting the clinical hold. But then, just as soon as it gets lifted, we no longer pursue the BLA for HIV as a 1st priority? It's actually now a 5th priority? When all this $$, time, and effort was invested to get the hold lifted? the same would be applied to writing the BLA since the data they are auditing right now to obtain the aggregated safety data which is necessary for lifting the clinical hold, is the same data which needs to be entered into the missing blank fields in the BLA which was submitted.
I think we are already 2/3 the way in submitting the application for approval. We have invested all this already. Why makes this anything less that #1 or #2 priority?
There are other regulatory committees and they meet weekly and see how its going, all to drop the clinical hold.
I think the meeting should happen in September maybe towards mid or late month.
So all this work towards lifting the clinical hold. But then, just as soon as it gets lifted, we no longer pursue the BLA for HIV as a 1st priority? It's actually now a 5th priority? When all this $$, time, and effort was invested to get the hold lifted? the same would be applied to writing the BLA since the data they are auditing right now to obtain the aggregated safety data which is necessary for lifting the clinical hold, is the same data which needs to be entered into the missing blank fields in the BLA which was submitted.
I think we are already 2/3 the way in submitting the application for approval. We have invested all this already. Why makes this anything less that #1 or #2 priority?
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