(Total Views: 509)
Posted On: 11/16/2023 9:08:07 PM
Post# of 148878
you may be right about this. In reality, the history of this stock price is written in violent moves up (and long drawn out declines). So if we do have a big positive catalyst, i agree there is the potential for a massive move in a short period of time.
so it really comes down to how quickly the hold is lifted. my biggest nagging concern on having the hold lifted is this:
The original hold inquiry was 5 tangible items i think. Cyrus laid them out, and actually kept us updated on the progress ("we've completed 3 of the 5", etc.). So we had a pretty black and white list of deliverables - which as far as i can understand, we delivered. The hold should then have been lifted - because the hold was based on 2 deaths and the concern they were tied our drug, and we proved they were not.
This second inquiry (i.e. wild goose chase) veered of the topic of safety - and to me seemed more amorphous - i'm not sure as an investor i ever saw the exact list of items? I know it included future plans for HIV, meetings with Key Opinion Leaders, etc. A lot of information was provided to the FDA - some seemingly subjective vs. objective (i.e. KOL feedback).
My point is - if the FDA didn't lift the safety-related hold when we clearly delivered 5 tangible items to show the drug's safety - what are the chances they simply lift the hold without further questions when the deliverables seemed so much more random, subjective and less concrete?
Hopefully - they look at the original submission (showing the drug is safe) and then say "ok, these guys did a lot of work - let's throw them a bone, because the hold should have been lifted already anyway". That would be the reasonable approach. But we're dealing with the FDA here - not the most reasonable group...
so it really comes down to how quickly the hold is lifted. my biggest nagging concern on having the hold lifted is this:
The original hold inquiry was 5 tangible items i think. Cyrus laid them out, and actually kept us updated on the progress ("we've completed 3 of the 5", etc.). So we had a pretty black and white list of deliverables - which as far as i can understand, we delivered. The hold should then have been lifted - because the hold was based on 2 deaths and the concern they were tied our drug, and we proved they were not.
This second inquiry (i.e. wild goose chase) veered of the topic of safety - and to me seemed more amorphous - i'm not sure as an investor i ever saw the exact list of items? I know it included future plans for HIV, meetings with Key Opinion Leaders, etc. A lot of information was provided to the FDA - some seemingly subjective vs. objective (i.e. KOL feedback).
My point is - if the FDA didn't lift the safety-related hold when we clearly delivered 5 tangible items to show the drug's safety - what are the chances they simply lift the hold without further questions when the deliverables seemed so much more random, subjective and less concrete?
Hopefully - they look at the original submission (showing the drug is safe) and then say "ok, these guys did a lot of work - let's throw them a bone, because the hold should have been lifted already anyway". That would be the reasonable approach. But we're dealing with the FDA here - not the most reasonable group...
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