Items that were due to be completed July 15 (for H
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Posted On: 07/16/2021 10:08:23 AM
Items that were due to be completed July 15 (for HIV BLA):
BLA Module One - administrative
BLA Module Four - Non-clinical reports
Probably will be mentioned in the next PR, maybe Monday morning. Those two items are likely not worthy of a PR on their own.
Important items we would like to hear about:
1. First injections in Brazil. I think the last statement was "hopefully by the end of July," so anything sooner would be a surprise.
2. Also, it would be nice to hear a "next step" about the Draft Dose Justification report we submitted on June 30. I think that triggered a 30 day period during which FDA was going to review and provide feedback on how to best move forward with the balance of the BLA submission.
3. Seems that they owe us a more detailed analysis of the LH trial results. And, maybe an update on the "bio-marker" research that Dr Recknor mentioned.
As an aside, it isn't entirely clear to me that our "rolling review" approval has been re-instated.
BLA Module One - administrative
BLA Module Four - Non-clinical reports
Probably will be mentioned in the next PR, maybe Monday morning. Those two items are likely not worthy of a PR on their own.
Important items we would like to hear about:
1. First injections in Brazil. I think the last statement was "hopefully by the end of July," so anything sooner would be a surprise.
2. Also, it would be nice to hear a "next step" about the Draft Dose Justification report we submitted on June 30. I think that triggered a 30 day period during which FDA was going to review and provide feedback on how to best move forward with the balance of the BLA submission.
3. Seems that they owe us a more detailed analysis of the LH trial results. And, maybe an update on the "bio-marker" research that Dr Recknor mentioned.
As an aside, it isn't entirely clear to me that our "rolling review" approval has been re-instated.
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