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Posted On: 09/10/2020 6:55:17 PM
Post# of 148903
I am betting that you are correct ohm20, "they're expecting some news between now and the 16th". I think they had "a very successful FDA meeting concerning CytoDyn’s upcoming HIV BLA" which is why they have stated that will be a topic on the agenda. That meeting's result, how to file the upcoming HIV BLA, is known at this point and they are going to give us the details next Wednesday and they are happy with how it went down.
As for the "ongoing discussions with the FDA and the U.K. Medicines & Healthcare product Regulatory Agency (MHRA)" my guess is that they do not know all the answers yet but are hopeful they may have answers by next Wednesday. If not, they will simply update us.
With regards to MHRA specifically...
If this first meeting was in fact the Promising Innovative Medicine (PIM) meeting, take some guidance from Remdesivir's Timeline
Assuming we are following the same process, you'll note that it took 7 days (Tues-Tues) from PIM designation to Scientific Opinion. I hope to hear where we are in this process next Wednesday. Are we waiting to find out if we got PIM based on our Wednesday meeting? Did we already get PIM and are waiting on the Scientific Opinion? These details will help us understand where we are in the process .
The good news is that MHRA is progressing through these steps quickly for COVID as evidenced by Remdesivir's timeline.
As for the "ongoing discussions with the FDA and the U.K. Medicines & Healthcare product Regulatory Agency (MHRA)" my guess is that they do not know all the answers yet but are hopeful they may have answers by next Wednesday. If not, they will simply update us.
With regards to MHRA specifically...
If this first meeting was in fact the Promising Innovative Medicine (PIM) meeting, take some guidance from Remdesivir's Timeline
Quote:
Further to the designation of Promising Innovative Medicine (PIM) status for remdesivir on 19 May 2020 (EAMS Step 1), MHRA issued a positive Scientific Opinion on 26 May 2020 which supports remdesivir for the following:
Assuming we are following the same process, you'll note that it took 7 days (Tues-Tues) from PIM designation to Scientific Opinion. I hope to hear where we are in this process next Wednesday. Are we waiting to find out if we got PIM based on our Wednesday meeting? Did we already get PIM and are waiting on the Scientific Opinion? These details will help us understand where we are in the process .
The good news is that MHRA is progressing through these steps quickly for COVID as evidenced by Remdesivir's timeline.
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