“You guys think emergency approval could come to
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Posted On: 04/09/2020 10:58:06 AM
Re: Coocooburra #26480
“You guys think emergency approval could come today?”
IMO, there is little to no chance of this happening.
The data from these early patient’s is promising, even more so when considering that laboratory tests are confirming leronlimab’s MOA and correlating with clinical recovery. But, the problem with emergency approval of leronlimab is:
1. The FDA’s standard for clinical trials and their adherence to these standards (i.e. the continual increase of the trial size for the severely ill patients).
2. The small amount of patients so far showing these results (only data from 7 now). I would’ve liked for NP to wait and report data on all 15 instead of only 7 (similar to filing for mTNBC BTD with data from only a handful of patients, which didn’t work).
And I believe the market views today’s PRs the same way that I do: great news, but not enough to get the FDA to move quicker in regards to approval. The next leg up for CYDY only comes with data (laboratory and clinical) from a larger number of patients that cannot be denied by the FDA.
My opinion is that the early look at the first 50 patients in the severely ill trial trial will be the game changer. That trial has a placebo arm and that will make the data irrefutable. Combine that with the data from the EIND patients, and from the mild/moderate trial, and the FDA will be unable to deny it. My only concern with that trial is the speed of enrollment. NP says the trial could be filled in a week, but will it actually be filled quickly? How long will it take to get 2 full weeks of data from 50 patients? 1 month? 2 months?
IMO, there is little to no chance of this happening.
The data from these early patient’s is promising, even more so when considering that laboratory tests are confirming leronlimab’s MOA and correlating with clinical recovery. But, the problem with emergency approval of leronlimab is:
1. The FDA’s standard for clinical trials and their adherence to these standards (i.e. the continual increase of the trial size for the severely ill patients).
2. The small amount of patients so far showing these results (only data from 7 now). I would’ve liked for NP to wait and report data on all 15 instead of only 7 (similar to filing for mTNBC BTD with data from only a handful of patients, which didn’t work).
And I believe the market views today’s PRs the same way that I do: great news, but not enough to get the FDA to move quicker in regards to approval. The next leg up for CYDY only comes with data (laboratory and clinical) from a larger number of patients that cannot be denied by the FDA.
My opinion is that the early look at the first 50 patients in the severely ill trial trial will be the game changer. That trial has a placebo arm and that will make the data irrefutable. Combine that with the data from the EIND patients, and from the mild/moderate trial, and the FDA will be unable to deny it. My only concern with that trial is the speed of enrollment. NP says the trial could be filled in a week, but will it actually be filled quickly? How long will it take to get 2 full weeks of data from 50 patients? 1 month? 2 months?
(2)
(1)CytoDyn Inc (CYDY) Stock Research Links
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