Help-2 clarification questions re: AF 10k article
He wrote two items in his 10k article this morning that I'm unsure of, can someone here clarify?
1. Indicated that CYDY asked the FDA for "breakthrough therapy designation" for leronlimab for HIV & Cancer but got turned down both times, is that accurate or misleading?
2. Indicated that their patents for leronlimab begin expiring in 2023, again - accurate or misleading?
Fwiw, I saw this comment posted by someone on his website in retaliation to his article, sounds right to me...
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George S
August 17, 2020 at 8:33 am
Thanks for the post. I would note that the 10k is for the period ending 5/31, there have been several developments since then which you neglect to mention have reversed some of the statements made in your article.
Specifically:
-The additional capital raise of $25mm to the company that easily funds them through the next several quarters which include the potential for FDA approval of their HIV indication + EUA in multiple countries (US, Mexico, UK, EU, Philippines) which will provide an immediate stream of revenues given the vials they have on hand.
-The achievement of the statistically significant secondary endpoint in the NEWS2 protocol in their Phase 2 M/M trial that will either allow for a FDA EUA and/or EUA’s in the aforementioned countries (UK designed NEWS2 and puts a great deal of weight on that endpoint)
-You reference the refusal-to-file letter in July in the same paragraph that you flag they will be submitting their HIV application by year-end (“a longer delay”) but again this is a 10-k for 5/31…sounds like cherry-picking as they have already requested the Type A FDA meeting which should have the date set any day now (FDA has 30 days to set a date for a Type A meeting request) where the data presented in the BLA can be cleared up so the filing can be properly analyzed given the primary endpoint was achieved with about as high a safety profile as you will find in any drug
Additionally, virtually every biotech has the same ongoing concern statement as every biotech startup has no revenue stream and only costs.
As for not achieving their Covid primary endpoint, that’s only in the Phase 2 and if they had listed NEWS2 as the primary, they would have achieved it. They did achieve clinical significance in their primary endpoint which you fail to mention. It wasn’t statistically significant simply because the number of patients (the “n”) wasn’t high enough. Additionally they can easily design a Phase 3 with NEWS2 as the primary endpoint and once that is achieved (which, if the number of patients is higher, it will be since it already was in Phase 2), approval should be given.
They already have a distribution and supply agreement in place (again, after the 5/31 10-K period) with American Regent for the Covid indication. They also already have a manufacturing agreement for their vials with Samsung (and 1.1mm vials filled with potential revenue ready to go). Lastly, the addition of nearly a dozen experts in their respective fields to their board within the past few weeks (ranging from cancer to HIV to MS to NASH, etc…) is impressive.
Yes they have one drug currently but it has a tremendous number of indications. Penicillin is one drug as well, if a biotech invented that, would they be limited in their potential?
I am a subscriber to Stat in the hopes that your articles will reveal deep insights, not simply focus on cherry picked statements without flushing out the full picture or present both sides to the story."
He wrote two items in his 10k article this morning that I'm unsure of, can someone here clarify?
1. Indicated that CYDY asked the FDA for "breakthrough therapy designation" for leronlimab for HIV & Cancer but got turned down both times, is that accurate or misleading?
2. Indicated that their patents for leronlimab begin expiring in 2023, again - accurate or misleading?
Fwiw, I saw this comment posted by someone on his website in retaliation to his article, sounds right to me...
"
George S
August 17, 2020 at 8:33 am
Thanks for the post. I would note that the 10k is for the period ending 5/31, there have been several developments since then which you neglect to mention have reversed some of the statements made in your article.
Specifically:
-The additional capital raise of $25mm to the company that easily funds them through the next several quarters which include the potential for FDA approval of their HIV indication + EUA in multiple countries (US, Mexico, UK, EU, Philippines) which will provide an immediate stream of revenues given the vials they have on hand.
-The achievement of the statistically significant secondary endpoint in the NEWS2 protocol in their Phase 2 M/M trial that will either allow for a FDA EUA and/or EUA’s in the aforementioned countries (UK designed NEWS2 and puts a great deal of weight on that endpoint)
-You reference the refusal-to-file letter in July in the same paragraph that you flag they will be submitting their HIV application by year-end (“a longer delay”) but again this is a 10-k for 5/31…sounds like cherry-picking as they have already requested the Type A FDA meeting which should have the date set any day now (FDA has 30 days to set a date for a Type A meeting request) where the data presented in the BLA can be cleared up so the filing can be properly analyzed given the primary endpoint was achieved with about as high a safety profile as you will find in any drug
Additionally, virtually every biotech has the same ongoing concern statement as every biotech startup has no revenue stream and only costs.
As for not achieving their Covid primary endpoint, that’s only in the Phase 2 and if they had listed NEWS2 as the primary, they would have achieved it. They did achieve clinical significance in their primary endpoint which you fail to mention. It wasn’t statistically significant simply because the number of patients (the “n”) wasn’t high enough. Additionally they can easily design a Phase 3 with NEWS2 as the primary endpoint and once that is achieved (which, if the number of patients is higher, it will be since it already was in Phase 2), approval should be given.
They already have a distribution and supply agreement in place (again, after the 5/31 10-K period) with American Regent for the Covid indication. They also already have a manufacturing agreement for their vials with Samsung (and 1.1mm vials filled with potential revenue ready to go). Lastly, the addition of nearly a dozen experts in their respective fields to their board within the past few weeks (ranging from cancer to HIV to MS to NASH, etc…) is impressive.
Yes they have one drug currently but it has a tremendous number of indications. Penicillin is one drug as well, if a biotech invented that, would they be limited in their potential?
I am a subscriber to Stat in the hopes that your articles will reveal deep insights, not simply focus on cherry picked statements without flushing out the full picture or present both sides to the story."
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