I have spent quite a bit of time trying to unpack
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Posted On: 09/06/2020 10:30:37 PM
I have spent quite a bit of time trying to unpack the timeline that was presented to us, and I still can't figure it out.
This is my understanding of the events:
- CytoDyn did, in fact, ask for the Type A Meeting
- CytoDyn told us the FDA was very busy
- CytoDyn said that a meeting would take a long time to schedule
- FDA said they could respond more quickly as a WRO (Written Response Only)
- CytoDyn did submit written questions to the FDA
- FDA said they would respond to the questions with a WRO by September 4
- CytoDyn said during the CC that the FDA responded the day before on September 1
And right before the CC starts, we receive a PR that indicates:
- FDA scheduled a Type A Meeting on September 8 -- that they formerly indicated would not be possible in the near term
- FDA has offered a 30+ day Multidisciplinary Review
In my opinion, there's no amount of hypothesizing that will get us any closer to the truth of what is going on here.
It is my opinion that the FDA is kicking the can down the road for another 30+ days, at a time when they should simply accept the BLA and grant a PDUFA date based on the unreasonable dosage change that THEY instituted, and the request for the time consuming CD03 700mg Integrated Assessment that THEY demanded.
My opinion -- something isn't quite right. It seems to me that the FDA intentionally changed the dosage to 700mg so that they could leverage it at a later time to further delay the BLA. They're not doing us any favors.
This is my understanding of the events:
- CytoDyn did, in fact, ask for the Type A Meeting
- CytoDyn told us the FDA was very busy
- CytoDyn said that a meeting would take a long time to schedule
- FDA said they could respond more quickly as a WRO (Written Response Only)
- CytoDyn did submit written questions to the FDA
- FDA said they would respond to the questions with a WRO by September 4
- CytoDyn said during the CC that the FDA responded the day before on September 1
And right before the CC starts, we receive a PR that indicates:
Quote:So now we are told:
In addition, the U.S. Food and Drug Administration (FDA) advised the Company the agency has scheduled a Type A meeting on September 8, 2020, following the Company’s receipt of the agency’s written responses on September 1 concerning it Biologic License Application (BLA) for leronlimab as a combination therapy for highly treatment-experienced HIV patients. The FDA clarified the items it needed primarily related to dosage levels.
- FDA scheduled a Type A Meeting on September 8 -- that they formerly indicated would not be possible in the near term
- FDA has offered a 30+ day Multidisciplinary Review
In my opinion, there's no amount of hypothesizing that will get us any closer to the truth of what is going on here.
It is my opinion that the FDA is kicking the can down the road for another 30+ days, at a time when they should simply accept the BLA and grant a PDUFA date based on the unreasonable dosage change that THEY instituted, and the request for the time consuming CD03 700mg Integrated Assessment that THEY demanded.
My opinion -- something isn't quite right. It seems to me that the FDA intentionally changed the dosage to 700mg so that they could leverage it at a later time to further delay the BLA. They're not doing us any favors.
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