Thank you Closet. I appreciate your clarifying qu
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Posted On: 02/15/2020 10:35:41 AM
Re: ClosetInvestor #18417
Thank you Closet. I appreciate your clarifying questions, and hope this will better explain my earlier questions.
I also don't understand why they are delaying the BLA. That is the question I'm trying to figure out. On the surface, it makes no sense, of course. At one point, I thought it could be the lack of cash.
I don't take all of the excuses at face value. If all the excuses are true, then it seems to me that many/most of the predictions of "soon" or "end of month" must have been intentionally false. (Again, seems to me.) I just don't think the CEO could be accidentally that bad at making predictions.
In searching for the "why", I guess I connected the BTD/cancer to the BLA/HIV. I realize they are different. I'm wondering if perhaps there is something wrong in their mind with the HIV plan. Maybe there is something in the data that they fear the FDA won't like (e.g. won't interpret that same way that CYDY has).
Maybe they feel that an HIV approval will somehow disadvantage a cancer approval? (I have no scientific idea why this would be. Maybe they fear the HIV approval would force a lower product price than a cancer approval? Is that a valid thought?).
But, it seems to me that they are pushing out the BLA filing to see if they can get more positive info about cancer. Perhaps with the idea of switching the entire approval to cancer (seems that would take a very long time, but clearly has more value. And, yes, I somewhat understand the whole off-label discussion). Is it possible that they could somehow increase the chances of an HIV approval if the Cancer data is strong (I know, apples and oranges again).
To repeat, my gut tells me they don't want to do the BLA filing on HIV right now. Makes no sense, but that is what it feels like.
I also don't understand why they are delaying the BLA. That is the question I'm trying to figure out. On the surface, it makes no sense, of course. At one point, I thought it could be the lack of cash.
I don't take all of the excuses at face value. If all the excuses are true, then it seems to me that many/most of the predictions of "soon" or "end of month" must have been intentionally false. (Again, seems to me.) I just don't think the CEO could be accidentally that bad at making predictions.
In searching for the "why", I guess I connected the BTD/cancer to the BLA/HIV. I realize they are different. I'm wondering if perhaps there is something wrong in their mind with the HIV plan. Maybe there is something in the data that they fear the FDA won't like (e.g. won't interpret that same way that CYDY has).
Maybe they feel that an HIV approval will somehow disadvantage a cancer approval? (I have no scientific idea why this would be. Maybe they fear the HIV approval would force a lower product price than a cancer approval? Is that a valid thought?).
But, it seems to me that they are pushing out the BLA filing to see if they can get more positive info about cancer. Perhaps with the idea of switching the entire approval to cancer (seems that would take a very long time, but clearly has more value. And, yes, I somewhat understand the whole off-label discussion). Is it possible that they could somehow increase the chances of an HIV approval if the Cancer data is strong (I know, apples and oranges again).
To repeat, my gut tells me they don't want to do the BLA filing on HIV right now. Makes no sense, but that is what it feels like.
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