The Keytruda silence is deafening. I am struggling
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Posted On: 04/11/2023 9:49:20 PM
The Keytruda silence is deafening. I am struggling to see the sp move north substantially in 2023 unless a potent catalyst emerges in oncology over the next. 6 months.
From the call, it sounds like our small management team will have its hands full over the next 6-9 months filing submission after submission trying to appease the FDA to lift the safety related clinical hold on what is probably one of the safest drugs ever developed, and trying to get protocols approved by the FDA for a NASH trial and perhaps a HIV trial. I doubt that even success on any of these fronts within that time frame will move the moribund sp significantly or with lasting effect. Ditto: naming Cyrus CEO or hiring a CMO. A favorable Amarex settlement would likely provide a favorable jolt to the sp, but the money from it would essentially just buy time.
If you agree with the above, that leaves oncology, ie, cancer. And I submit that a partnership (or BO) on satisfactory terms is the most reasonable hope for substantial sp improvement in 2023. I would feel much better about LL's chances for FDA approval if paired with a BP drug, and the reigning champ is Keytruda.
After Cyrus volunteered the Keytruda/LL combo treatment in Professor Lee's breast cancer mouse study in the Biospace article 2 weeks ago, it is not logical that there would be no further mention of that study or hardly any reference to CYDY's oncology plans today. It's been suggested that perhaps Cyrus doesn't know the outcome of the study, but I find it hard to believe that CYDY would provide LL for the study without the right to learn the results. It's possible the study isn't finished, but 18 months is more than enough time for multiple mouse studies. I agree with ohm and others that awaiting publication of a peer reviewed paper could explain the silence today, or that Merck or a NDA may have muzzled Cyrus. But I don't buy Cyrus mentioning Keytruda 2 weeks ago unless he knew or had strong reason to believe that the combo had produced good results.
Keep in mind how critical it is for Merck to extend Keytruda's patent beyond its looming patent cliff, and that LL, perhaps more than other combo drug, might meet the unexpected success (non obvious) criterion to merit extension of the patent. This would be a match made in heaven if LL substantially increased Keytruda's efficacy and extended its patent at the same time. (And since I buy ohm's analysis that LL by itself will probably be as efficacious as the combo, I doubt that Merck would let Professor Lee or anyone else compare LL with LL/Keytruda.)
It's very possible that what I strain to see as a rational argument for a major 2023 catalyst is in reality a classic house of cards. But I am unwilling, even now, to write off 2023 as so much wheel spinning. So I'm hunkering down with the sound of silence as my north star until or unless future developments betray me.
From the call, it sounds like our small management team will have its hands full over the next 6-9 months filing submission after submission trying to appease the FDA to lift the safety related clinical hold on what is probably one of the safest drugs ever developed, and trying to get protocols approved by the FDA for a NASH trial and perhaps a HIV trial. I doubt that even success on any of these fronts within that time frame will move the moribund sp significantly or with lasting effect. Ditto: naming Cyrus CEO or hiring a CMO. A favorable Amarex settlement would likely provide a favorable jolt to the sp, but the money from it would essentially just buy time.
If you agree with the above, that leaves oncology, ie, cancer. And I submit that a partnership (or BO) on satisfactory terms is the most reasonable hope for substantial sp improvement in 2023. I would feel much better about LL's chances for FDA approval if paired with a BP drug, and the reigning champ is Keytruda.
After Cyrus volunteered the Keytruda/LL combo treatment in Professor Lee's breast cancer mouse study in the Biospace article 2 weeks ago, it is not logical that there would be no further mention of that study or hardly any reference to CYDY's oncology plans today. It's been suggested that perhaps Cyrus doesn't know the outcome of the study, but I find it hard to believe that CYDY would provide LL for the study without the right to learn the results. It's possible the study isn't finished, but 18 months is more than enough time for multiple mouse studies. I agree with ohm and others that awaiting publication of a peer reviewed paper could explain the silence today, or that Merck or a NDA may have muzzled Cyrus. But I don't buy Cyrus mentioning Keytruda 2 weeks ago unless he knew or had strong reason to believe that the combo had produced good results.
Keep in mind how critical it is for Merck to extend Keytruda's patent beyond its looming patent cliff, and that LL, perhaps more than other combo drug, might meet the unexpected success (non obvious) criterion to merit extension of the patent. This would be a match made in heaven if LL substantially increased Keytruda's efficacy and extended its patent at the same time. (And since I buy ohm's analysis that LL by itself will probably be as efficacious as the combo, I doubt that Merck would let Professor Lee or anyone else compare LL with LL/Keytruda.)
It's very possible that what I strain to see as a rational argument for a major 2023 catalyst is in reality a classic house of cards. But I am unwilling, even now, to write off 2023 as so much wheel spinning. So I'm hunkering down with the sound of silence as my north star until or unless future developments betray me.
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