Agree - it's clearly an "uneven playing field," bu
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Posted On: 10/28/2020 4:20:34 PM
Agree - it's clearly an "uneven playing field," but is that the same as a "corrupt decider?"
As you note, brand recognition can make patients comfortable joining BP trials. Hard on a small bio. Is it FDA's job to actively offset market biases like these? Somewhat, maybe?
Let me take this in a pro-NP direction for a moment.
Along with finding a useful compound (grade A+) and raising money as needed (rating A+), the most important skill of a clinical stage bio CEO is getting patients into trials - CYDY has over 1,000 in roughly 11 trials. That involves managing the FDA and the medical community. Rating A+.
Back to the FDA: they do have some weapons that (even unintentionally) can offset market biases and the inexperience of small bios, including breakthrough designation (great for recruitment) and rolling review (to lead the company through process). NP nabbed 3 of these. Rating A+.
Next, the mixed reviews: Wildly cost efficient ($300m) bringing large-opportunity drug to BLA filing (rating A+), but not that time-efficient (rating C, but consider time cost of reconstructing manufacturing documentation).
Saving the most important for last: scoring in the red zone: Some unforced bobbles (partially thank the CRO?) but steady advancement where others, including BP, have fallen (CD12).
The only rating possible is "incomplete." Watch this space.
As you note, brand recognition can make patients comfortable joining BP trials. Hard on a small bio. Is it FDA's job to actively offset market biases like these? Somewhat, maybe?
Let me take this in a pro-NP direction for a moment.
Along with finding a useful compound (grade A+) and raising money as needed (rating A+), the most important skill of a clinical stage bio CEO is getting patients into trials - CYDY has over 1,000 in roughly 11 trials. That involves managing the FDA and the medical community. Rating A+.
Back to the FDA: they do have some weapons that (even unintentionally) can offset market biases and the inexperience of small bios, including breakthrough designation (great for recruitment) and rolling review (to lead the company through process). NP nabbed 3 of these. Rating A+.
Next, the mixed reviews: Wildly cost efficient ($300m) bringing large-opportunity drug to BLA filing (rating A+), but not that time-efficient (rating C, but consider time cost of reconstructing manufacturing documentation).
Saving the most important for last: scoring in the red zone: Some unforced bobbles (partially thank the CRO?) but steady advancement where others, including BP, have fallen (CD12).
The only rating possible is "incomplete." Watch this space.
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