Only the clinical section of the BLA required BLA
Post# of 148190
(Total Views: 605)
Posted On: 01/21/2020 11:10:58 AM
Re: craigakess #15578
Only the clinical section of the BLA required BLA input.
The Mfg piece only required the completed stability data we were the told. The reality is stability data is gathered at various time points after the samples are put in the stability chamber so realistically the bulk of the submission could have been drafted and proofed just waiting for the test results from the last stability time point which could be analyzed and added in the appropriate spot in the submission very quickly after receipt. The rest of the submission should have been fully prepped while the team waited for the last time point.
This section is squarely on CYDY and its current Mfg partner and is later than it should be.
In my opinion only
The Mfg piece only required the completed stability data we were the told. The reality is stability data is gathered at various time points after the samples are put in the stability chamber so realistically the bulk of the submission could have been drafted and proofed just waiting for the test results from the last stability time point which could be analyzed and added in the appropriate spot in the submission very quickly after receipt. The rest of the submission should have been fully prepped while the team waited for the last time point.
This section is squarely on CYDY and its current Mfg partner and is later than it should be.
In my opinion only
(1)
(0)CytoDyn Inc (CYDY) Stock Research Links
Scroll down for more posts ▼