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Posted On: 09/14/2020 12:00:01 PM
Post# of 148936
Re: Goosebumps #55697
I appreciate your optimism, but I am compelled to make some clarifications.
On Wednesday, we will learn if we are taking the FDA up on their offer of an Interdisciplinary Review, which will take no less than 30-days AFTER we provide them with a revised submission package. I personally hope CytoDyn takes this path, as it can ill-afford to give the FDA another reason to delay or deny our filing.
After we officially re-file the revised BLA, we will wait 60-days to learn if the FDA issues another RTF, or 74-days to learn if they accept the BLA and issue a PDUFA date. If we receive a PDUFA date, and the FDA accepts our request for Priority Review, we can expect a final ruling within 6 months.
So, the chances of the BLA being approved in 4 weeks is zero.
We have been informed that a Preliminary Meeting for Breakthrough Therapy Designation was anticipated for September. This is a meeting that is typically granted PRIOR to a BTD filing. In our case, it is being granted after a wildly premature and unsuccessful BTD filing earlier this year. It is also worth mentioning that we haven't heard anything regarding this meeting for months -- so it's anyone's guess as to whether or not it's even still on the docket.
So, in my opinion, the chances of a BTD filing in September are zero.
Lastly, a number of people on this board seem to think I am a basher or a pessimist. Neither are true. I try to be an objective, eyes-wide-open realist, and I try to assess upside opportunity and downside risk without bias. However, that doesn't make me immune to episodes of optimism -- as well as periods of concern. The manner by which this company disseminates information does not make it any easier, which I can say with confidence after meticulously drafting dozens of Catalyst Lists.
Quote:As much as I would like this to happen, and agree that the optics of this approach would make sense -- it will never happen. We don't even have an accepted BLA.
IMO they may want to approve HIV BLA at the same time as Covid to quote and use the safety profile of HIV. Essentially making it real to the public. It would make sense. Can’t just say... we have an excellent safety profile without reference filed.
On Wednesday, we will learn if we are taking the FDA up on their offer of an Interdisciplinary Review, which will take no less than 30-days AFTER we provide them with a revised submission package. I personally hope CytoDyn takes this path, as it can ill-afford to give the FDA another reason to delay or deny our filing.
After we officially re-file the revised BLA, we will wait 60-days to learn if the FDA issues another RTF, or 74-days to learn if they accept the BLA and issue a PDUFA date. If we receive a PDUFA date, and the FDA accepts our request for Priority Review, we can expect a final ruling within 6 months.
So, the chances of the BLA being approved in 4 weeks is zero.
Quote:Again, as much as I would like for this to happen, we are not filing for a BTD in September.
We also have BTD for MTNBC to be filed soon per Nader. was mentioned to file in September.
We have been informed that a Preliminary Meeting for Breakthrough Therapy Designation was anticipated for September. This is a meeting that is typically granted PRIOR to a BTD filing. In our case, it is being granted after a wildly premature and unsuccessful BTD filing earlier this year. It is also worth mentioning that we haven't heard anything regarding this meeting for months -- so it's anyone's guess as to whether or not it's even still on the docket.
So, in my opinion, the chances of a BTD filing in September are zero.
Lastly, a number of people on this board seem to think I am a basher or a pessimist. Neither are true. I try to be an objective, eyes-wide-open realist, and I try to assess upside opportunity and downside risk without bias. However, that doesn't make me immune to episodes of optimism -- as well as periods of concern. The manner by which this company disseminates information does not make it any easier, which I can say with confidence after meticulously drafting dozens of Catalyst Lists.
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