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Posted On: 11/17/2023 9:35:49 AM
Post# of 148863
I do believe we spike on the news of the hold being released, I just don't know how high. It could catch enough shorts off guard that the scramble to exit positions jumps it over a buck. Or it doesn't get close to that and only bumps up toward .50.
From there though, it's anyone's guess. I think it's entirely possible to see some really significant increases if we get quick news after the hold about either a partnership with a legit big pharma company or an announcement that a BLA is back in business with a near term possibility of an approval.
As far as a big pharma partner, I'm talking about Gilead or Merck level companies. If they're throwing around possibilities of combining LL eventually with a Keytruda, for instance, that should be quite the catapult for our price. But if it's a partnership with an unknown group with 8 employees we'll see the mechanism fail before the catapult even starts to pull. If they announce that Craig's Biotech & Animal Husbandry LLC has offered a very generous percentage on future sales for US rights I think we'd see the price fall.
In regards to a BLA, I'm not on board with the theory that they're just going to approve us out of the blue within a few weeks under guidance that we complete a phase 4 to shore up any missing information post approval. I think it's more likely that we either complete whatever that trial is first, or that we are allowed to resubmit a BLA, which gives the FDA six months to review and eventually approve. Either result would be fantastic, I just don't think we're going to jump from incomplete BLA that independent auditors say would fail instantly, to shoring up the safety hold and magically getting approval. If it took them two years to answer six questions from the FDA I can't imagine they also were able to complete a new BLA in that timeframe for the patient population they've just recently started to hone in on with the help of the FDA.
So while I like the idea of that reddit poster's 26 days to $35, I think it would take a lot longer than that for all of his predictions to play out. And I don't necessarily agree with all of them anyway. I'm not sold on the idea that Cytodyn moved their manufacturing tech somewhere else. I think the wording of the entire FAQ and letter, and specifically that paragraph where it's mentioned, means they were speaking historically of a significant hurdle that was achieved along the path to where we are now. Not a recent transfer that leads some to think a new partner will be taking that over.
I also don't think that announcing a MASH trial and getting it approved is something that happens quickly. They can announce they've submitted a protocol, but then the FDA will take 60+ days or something to review it and rubber stamp it.
But overall I do think we'll get news of the hold release followed by at least two more important PRs. Funding via a partnership of some kind should be one, and news about why the FDA hosted an ADCOM-style meeting about LL and HIV should be another. And those two or three things should help get us back into a respectable price range measured in dollars versus cents.
Oh, and up almost 4% right out of the gates today?
Somebody...
Must...
Know...
Something...
From there though, it's anyone's guess. I think it's entirely possible to see some really significant increases if we get quick news after the hold about either a partnership with a legit big pharma company or an announcement that a BLA is back in business with a near term possibility of an approval.
As far as a big pharma partner, I'm talking about Gilead or Merck level companies. If they're throwing around possibilities of combining LL eventually with a Keytruda, for instance, that should be quite the catapult for our price. But if it's a partnership with an unknown group with 8 employees we'll see the mechanism fail before the catapult even starts to pull. If they announce that Craig's Biotech & Animal Husbandry LLC has offered a very generous percentage on future sales for US rights I think we'd see the price fall.
In regards to a BLA, I'm not on board with the theory that they're just going to approve us out of the blue within a few weeks under guidance that we complete a phase 4 to shore up any missing information post approval. I think it's more likely that we either complete whatever that trial is first, or that we are allowed to resubmit a BLA, which gives the FDA six months to review and eventually approve. Either result would be fantastic, I just don't think we're going to jump from incomplete BLA that independent auditors say would fail instantly, to shoring up the safety hold and magically getting approval. If it took them two years to answer six questions from the FDA I can't imagine they also were able to complete a new BLA in that timeframe for the patient population they've just recently started to hone in on with the help of the FDA.
So while I like the idea of that reddit poster's 26 days to $35, I think it would take a lot longer than that for all of his predictions to play out. And I don't necessarily agree with all of them anyway. I'm not sold on the idea that Cytodyn moved their manufacturing tech somewhere else. I think the wording of the entire FAQ and letter, and specifically that paragraph where it's mentioned, means they were speaking historically of a significant hurdle that was achieved along the path to where we are now. Not a recent transfer that leads some to think a new partner will be taking that over.
I also don't think that announcing a MASH trial and getting it approved is something that happens quickly. They can announce they've submitted a protocol, but then the FDA will take 60+ days or something to review it and rubber stamp it.
But overall I do think we'll get news of the hold release followed by at least two more important PRs. Funding via a partnership of some kind should be one, and news about why the FDA hosted an ADCOM-style meeting about LL and HIV should be another. And those two or three things should help get us back into a respectable price range measured in dollars versus cents.
Oh, and up almost 4% right out of the gates today?
Somebody...
Must...
Know...
Something...
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