If we are all objective about the BLA submission d
Post# of 153990
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Posted On: 03/02/2020 9:37:11 AM
Re: craigakess #19903
If we are all objective about the BLA submission delays, we can attribute the clinical section delay to the additional Data requirements for the full 595 patient safety data. That does not excuse missing End of February for this section as this information has been known for some time and a quality submission should be considered when alternate dates like the end of Feb are communicated publicly.
More troubling for me, as I said multiple times, is the manufacturing (CMC) section. The FDA request for additional stability has been known for 6 months (since September/October) and the final stability time point was communicated as due in December. Even if you dismiss the question of why this stability request was a surprise, it is very hard to understand why the manufacturing section was not available in January at the latest as the entire submission should have been written and triple checked just waiting for the final stability checkpoint data to be entered into the submission.
Approved manufacturing is needed if we get a very positive BTD response with a confirmatory trial requirement and if that is the case, this Multiple month long delay will be costly for investors and patients.
We need info this week in CMC section as info on that section has been eerily quiet.
All IMO
More troubling for me, as I said multiple times, is the manufacturing (CMC) section. The FDA request for additional stability has been known for 6 months (since September/October) and the final stability time point was communicated as due in December. Even if you dismiss the question of why this stability request was a surprise, it is very hard to understand why the manufacturing section was not available in January at the latest as the entire submission should have been written and triple checked just waiting for the final stability checkpoint data to be entered into the submission.
Approved manufacturing is needed if we get a very positive BTD response with a confirmatory trial requirement and if that is the case, this Multiple month long delay will be costly for investors and patients.
We need info this week in CMC section as info on that section has been eerily quiet.
All IMO
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