My take fwiw...
My 2 cents (or my 2 dollars...too soon?)
The way I see it is the FDA was bombarded / deluded by folks pushing for LL EUA/approval. The lower downs through the higher ups were fed up with all the time it was 'wasting' and hassle it was creating given their hands were 'tied' given the lack of hitting primary endpoints. There was a push to try and quiet the storm so that any future complaints can be simply addressed by directing folks to this letter.
There is no positive commentary or mention of any positive outcomes within the trials (which we all know there were plenty of) because that would keep the door open to anyone trying to nitpick the PR and throw the FDA's own words back in its face. AKA, they had no choice but to be utterly & overly negative given the goal was to (attempt to) put a stop to the outcry.
Btw, we know how respectful CYDY has been wrt the FDA. This letter was literally aimed at shareholders & the medical community, NOT at CYDY. The FDA literally said as much in the last 2 paragraphs, read them closely... It wasn't CYDY complaining on social media, via emails, via videos, or anywhere for that matter...it was the collective 'us'.
What has actually changed in my mind? Not much.
-LL still binds to CCR5, the drug still works, no doors have been shut with regards to that, and imo that's the most important part
-FDA still on board w/ assisting them as needed w/ future trials
-EIND's & Open Label have not been shut down from what I can tell
-CD16/17 was likely always required to get this past the goal line - those are designed for slam dunk wins given the knowledge they have now
-CSP-style revenue potential still there in India, Philippines, Brazil, Canada, or the UK (who may need to re-lockdown due to the India variant)
-They just raised a ton of cash so liquidity not a problem in the short term
-Long haulers trial is super informative for them and will aid in PIII trial design + benefits for future trials
-Cancer trials still overwhelmingly positive (aka oncology company in future, Covid was just a bridge loan)
-HIV BLA should be resolved soon enough
I never thought the path to success here (& share px upward movement) would be straight, easy, or quick. Nor should anyone investing in a biotech. $2 is a steal with a 5-10 year time horizon, that's all I can say.
So again, what has changed here in my mind, not much. In fact I'm sure many of us could have predicted such a letter if we were asked "If the FDA were to make a public statement about LL right now, what would it be?". They are following the rulebook, unfortunately somewhat of a double-standard rulebook, but it is what it is.
My 2 cents (or my 2 dollars...too soon?)
The way I see it is the FDA was bombarded / deluded by folks pushing for LL EUA/approval. The lower downs through the higher ups were fed up with all the time it was 'wasting' and hassle it was creating given their hands were 'tied' given the lack of hitting primary endpoints. There was a push to try and quiet the storm so that any future complaints can be simply addressed by directing folks to this letter.
There is no positive commentary or mention of any positive outcomes within the trials (which we all know there were plenty of) because that would keep the door open to anyone trying to nitpick the PR and throw the FDA's own words back in its face. AKA, they had no choice but to be utterly & overly negative given the goal was to (attempt to) put a stop to the outcry.
Btw, we know how respectful CYDY has been wrt the FDA. This letter was literally aimed at shareholders & the medical community, NOT at CYDY. The FDA literally said as much in the last 2 paragraphs, read them closely... It wasn't CYDY complaining on social media, via emails, via videos, or anywhere for that matter...it was the collective 'us'.
What has actually changed in my mind? Not much.
-LL still binds to CCR5, the drug still works, no doors have been shut with regards to that, and imo that's the most important part
-FDA still on board w/ assisting them as needed w/ future trials
-EIND's & Open Label have not been shut down from what I can tell
-CD16/17 was likely always required to get this past the goal line - those are designed for slam dunk wins given the knowledge they have now
-CSP-style revenue potential still there in India, Philippines, Brazil, Canada, or the UK (who may need to re-lockdown due to the India variant)
-They just raised a ton of cash so liquidity not a problem in the short term
-Long haulers trial is super informative for them and will aid in PIII trial design + benefits for future trials
-Cancer trials still overwhelmingly positive (aka oncology company in future, Covid was just a bridge loan)
-HIV BLA should be resolved soon enough
I never thought the path to success here (& share px upward movement) would be straight, easy, or quick. Nor should anyone investing in a biotech. $2 is a steal with a 5-10 year time horizon, that's all I can say.
So again, what has changed here in my mind, not much. In fact I'm sure many of us could have predicted such a letter if we were asked "If the FDA were to make a public statement about LL right now, what would it be?". They are following the rulebook, unfortunately somewhat of a double-standard rulebook, but it is what it is.
17
1
