From YMB pretty succinct I believe. A REMINDER just in case that either FDA, UK MHRA or other drug agencies of this world would request a confirmatory phase III study with mild to moderate patients:
- A request for phase III means that results from phase II are appreciated and recognized (!) Normally biotechs do a nice jump north, if they are allowed to enter to enter the final phase III. If a phase II study failed in the eyes of the FDA, you are NOT ALLOWED to perform a phase III study !
- CYTODYN still would be FIRST ! To my best knowledge no other company has even studied mild and moderate Covid-19 patients. We have statistical significant phase II results on NEWS2 supported by other clinical endpoints showing clear trend in favor of leronlimab.
- There are about 20 - 50 times more mild & moderately ill Covid-19 patients as compared to severe and critical ill patients. Mild & moderate is by far the most abundant Covid-19 patient group !
- as a consequence, such confirmatory phase III trial would be really quick ! Currently CYDY is recruiting about 2 patients per day of severe or critical patients in the CD12 trial. 100 or 150 mild or moderate patients could be enrolled within a couple of weeks; lets be conservative and say 1 month.
- we have already a very meaning endpoint, i.e. "NEWS2" which we know we can hit !
- we have already study sites, contacts with doctors and hospitals in place,
- we have Amarex who could prepare a study 3 protocol by amending the phase 2 protocol within days (I would not be surprised if they did already)
- such study once finished for the purpose of EUA could be extended to study the effect of leronlimab regarding long term symptoms (long-haulers ! ). We could get funds for that and save an extra study for long-haulers.
- Finally: such phase III could be accepted by the FDA and other drug authorities not only for EUA, but also for full marketing authorisation that would allow off label us. In addition a full marketing authorisation would signficiantly increase the value of leronlimab (and of CYDY). And on top it would significantly ease the path for future applications such as cancer, NASH if leronlimab has already full marketing authorisation (and not "only" EUA).
- With phase III results nobody of the scientific community and neither "big pharma" lobbyists could argue against leronlimab.
Overall, such trial - yes, it would delay the EUA for a very few weeks, but we would gain a lot. If you ask me - worth if not desirable to do it. Downside, yes, there is also a downside: patients would need to wait longer - and some of the mild or moderate who could get leronlimab may even deteriorate and die, and we investors may need to wait a bit longer for the big burst into double-digit figures - although the BLA acceptance will bring us close or above 10 anyway within the next couple of weeks.
If you ask me, I would not be disappointed to do a confirmatory phase III trial with about 150 patients. We sill would be first with mild and moderate patients. And remember: the big numbers are not critically ill Covid-19 patients, it is the mild and moderate !
Some retail investors could be disappointed if we had to perform a confirmatory phase III study. I have considered that and sold another part of my gold ETF. That is planned to be my last (rather big) buy of CYDY. I am still very confident that we will be well beyond 10 USD by end of this year
- A request for phase III means that results from phase II are appreciated and recognized (!) Normally biotechs do a nice jump north, if they are allowed to enter to enter the final phase III. If a phase II study failed in the eyes of the FDA, you are NOT ALLOWED to perform a phase III study !
- CYTODYN still would be FIRST ! To my best knowledge no other company has even studied mild and moderate Covid-19 patients. We have statistical significant phase II results on NEWS2 supported by other clinical endpoints showing clear trend in favor of leronlimab.
- There are about 20 - 50 times more mild & moderately ill Covid-19 patients as compared to severe and critical ill patients. Mild & moderate is by far the most abundant Covid-19 patient group !
- as a consequence, such confirmatory phase III trial would be really quick ! Currently CYDY is recruiting about 2 patients per day of severe or critical patients in the CD12 trial. 100 or 150 mild or moderate patients could be enrolled within a couple of weeks; lets be conservative and say 1 month.
- we have already a very meaning endpoint, i.e. "NEWS2" which we know we can hit !
- we have already study sites, contacts with doctors and hospitals in place,
- we have Amarex who could prepare a study 3 protocol by amending the phase 2 protocol within days (I would not be surprised if they did already)
- such study once finished for the purpose of EUA could be extended to study the effect of leronlimab regarding long term symptoms (long-haulers ! ). We could get funds for that and save an extra study for long-haulers.
- Finally: such phase III could be accepted by the FDA and other drug authorities not only for EUA, but also for full marketing authorisation that would allow off label us. In addition a full marketing authorisation would signficiantly increase the value of leronlimab (and of CYDY). And on top it would significantly ease the path for future applications such as cancer, NASH if leronlimab has already full marketing authorisation (and not "only" EUA).
- With phase III results nobody of the scientific community and neither "big pharma" lobbyists could argue against leronlimab.
Overall, such trial - yes, it would delay the EUA for a very few weeks, but we would gain a lot. If you ask me - worth if not desirable to do it. Downside, yes, there is also a downside: patients would need to wait longer - and some of the mild or moderate who could get leronlimab may even deteriorate and die, and we investors may need to wait a bit longer for the big burst into double-digit figures - although the BLA acceptance will bring us close or above 10 anyway within the next couple of weeks.
If you ask me, I would not be disappointed to do a confirmatory phase III trial with about 150 patients. We sill would be first with mild and moderate patients. And remember: the big numbers are not critically ill Covid-19 patients, it is the mild and moderate !
Some retail investors could be disappointed if we had to perform a confirmatory phase III study. I have considered that and sold another part of my gold ETF. That is planned to be my last (rather big) buy of CYDY. I am still very confident that we will be well beyond 10 USD by end of this year
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