I just posted this on Yahoo and thought it was worth sharing here.
As I have a significant position in CYDY I can't say that I wasn't disappointed that CD12 did not merit an EUA in the eyes of the FDA. However between the 2 press releases, the Saturday night Dr. Been interview, and the conference call on Monday I believe that Nader said something that was missed. I'm not quoting him directly as I haven't the time to parse out the exact language.
He frequently uses the words 'approval' and 'authorization' and I think most shareholders think of those words interchangeably. That could be a function of Nader's somewhat broken English. I don't fault him for that, but it comes across even in the press releases, where his grammar shows that he is not a native English speaker.
On a side note, I believe that those printed grammatical errors are further proof that Nader is writing the press releases himself, with little or no oversight aside from the legal department. If ever a company could benefit from a proper press officer who can proofread and edit for clarity, it is Cytodyn. The messaging is so bad that shareholders often confuse good news for bad (although never the reverse unfortunately).
Back to my point. Approval is not the same as Authorization. Right now, all of the therapeutics for Covid-19 aside from dexamethasone are being used under the very conditional Emergency Use Authorization. This authorization gets rescinded when either the pandemic is declared over, or a BETTER DRUG GETS EUA for the same use/population.
Nader said on Monday that they may apply for 'conditional FDA authorization' while waiting for CD16 to complete. I think that management was discussing actual Approval with the FDA prior to CD12 readout because of the massive amount of drug data acquired from the HIV trials and the rolling BLA for that indication. When the results were only in line with previous EUAs (see Dr. Been's recent comments), the FDA suggested the CD16 trial design.
To be clear, I think they have been talking about Approval all along while we as shareholders have been tying our hopes to Authorization. They hired Dr. Mahboob U. Rahman to get the HIV BLA in shape but that has become a corporate priority that seems to have slipped further and further down the timeline. I believe that is because Dr. Rahman is using the rolling review for that BLA to build an entirely new BLA around Covid-19. The missing piece would only be trial data, something that after CD12 we now know needs to be filled with data from CD16. Remember, the other parts of a BLA (manufacturing, safety data, etc.) are universal and not specific to the indication being applied for.
If true, the importance of this can't be overstated. With an EUA for Covid-19 we are subject to losing the market for Leronlimab if the pandemic is downgraded or if another drug proves better efficacy in our target patient population. If management is in fact angling for Approval with a conditional Authorization to hold us over, then a successful CD16 means the race could be won without us even knowing.
Or maybe Nader just confuses the word 'approval' with 'authorization'. At this point anything is possible. Good luck longs.
As I have a significant position in CYDY I can't say that I wasn't disappointed that CD12 did not merit an EUA in the eyes of the FDA. However between the 2 press releases, the Saturday night Dr. Been interview, and the conference call on Monday I believe that Nader said something that was missed. I'm not quoting him directly as I haven't the time to parse out the exact language.
He frequently uses the words 'approval' and 'authorization' and I think most shareholders think of those words interchangeably. That could be a function of Nader's somewhat broken English. I don't fault him for that, but it comes across even in the press releases, where his grammar shows that he is not a native English speaker.
On a side note, I believe that those printed grammatical errors are further proof that Nader is writing the press releases himself, with little or no oversight aside from the legal department. If ever a company could benefit from a proper press officer who can proofread and edit for clarity, it is Cytodyn. The messaging is so bad that shareholders often confuse good news for bad (although never the reverse unfortunately).
Back to my point. Approval is not the same as Authorization. Right now, all of the therapeutics for Covid-19 aside from dexamethasone are being used under the very conditional Emergency Use Authorization. This authorization gets rescinded when either the pandemic is declared over, or a BETTER DRUG GETS EUA for the same use/population.
Nader said on Monday that they may apply for 'conditional FDA authorization' while waiting for CD16 to complete. I think that management was discussing actual Approval with the FDA prior to CD12 readout because of the massive amount of drug data acquired from the HIV trials and the rolling BLA for that indication. When the results were only in line with previous EUAs (see Dr. Been's recent comments), the FDA suggested the CD16 trial design.
To be clear, I think they have been talking about Approval all along while we as shareholders have been tying our hopes to Authorization. They hired Dr. Mahboob U. Rahman to get the HIV BLA in shape but that has become a corporate priority that seems to have slipped further and further down the timeline. I believe that is because Dr. Rahman is using the rolling review for that BLA to build an entirely new BLA around Covid-19. The missing piece would only be trial data, something that after CD12 we now know needs to be filled with data from CD16. Remember, the other parts of a BLA (manufacturing, safety data, etc.) are universal and not specific to the indication being applied for.
If true, the importance of this can't be overstated. With an EUA for Covid-19 we are subject to losing the market for Leronlimab if the pandemic is downgraded or if another drug proves better efficacy in our target patient population. If management is in fact angling for Approval with a conditional Authorization to hold us over, then a successful CD16 means the race could be won without us even knowing.
Or maybe Nader just confuses the word 'approval' with 'authorization'. At this point anything is possible. Good luck longs.
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