Lots of excitement about the upcoming BTD application. It is coming, with profound implications for Cytodyn. But nobody on this board--or Livimmune--has asked the vital question: what drug combination is Lalezari talking about? Is it the LL/Bev/Taz combo... or is it the LL/ICI combo? No one really knows. Lots of speculation. The Livimmune board more or less just figures it's the ICI combo. And they are already getting wet-in-the-pants about this... with no real discussion about the indication. Though lots of talk about the new haircut and suit! So MGK2 may write 556 words about it--not as a definitive post, but a response to a post by Gloomy-Lead4219--but no clue about the indication! I think this is a lot of rank speculation if you can't even define what indication/drug combo you are talking about. And no one has seen fit to mention this...
What are the implications of a BTD for a new LL/Bev/ Taz combo, vs a BTD for an ICI/LL combo? I would say it is a rapid AA for the triplet as the new SOC... and a slower process for the LL/ICI combo. And that is acknowledging the deliberate pace of the FDA in terms of novel drugs. So the easy path is to approve a BTD for the new SOC, while leaving room in the near future for the real radical explosion of efficacy that LL and an ICI apparently provides. (And another BTD!). "Apparently" is the key word here... while there are signs that the new FDA will rapidly move forward with novel cancer drugs that provide substantial benefit, they might have some problems understanding a multi-purpose immune modulator that actually works... and can exert it's therapeutic effects based on homeostasis (thank you Ohm) vs single MOAs like cancer-killing chemo or checkpoint inhibition. Like they can't get there head around a well-designed CCR5 inhibitor (thank you Paul Maddon) that performs way way better than maraviroc or the other CCR5 inhibitors that have been tested. Stupid fucks... (Unless they surprise me and move Leronlimab forward... I will humbly take it all back if they get their shit together!). But--can the RFKjr FDA get their heads into this? Ideology may get in the way here--there are a large number of failures with less-than-optimal CCR5 inhibitors. So saying "Prove It!" is not unreasonable. Lalezari is hell-bent on doing just that... and he is nothing but thorough. Like 35 years or so as head of a CRO that has worked with a variety of Big Pharma companies proving through well-designed trials whether their drugs work or not. It's not that his credibility is on the line... It's that he has earned his credibility.
(Jeff Fucking Murray may not agree--but the outing of his treatment of Cytodyn during the Covid crisis will bite his ass--and reputation--sooner or later. The history books will put a million or so lives on his mean-spirited, vile decisions when the world needed him to be open-minded and insightful about what kills severe covid patients--the over-reaction of the immune system, the cytokine storm... not the virus! Covid--like cancer--is a RANTES disease! Jeeze, even I could see that/learn that. After a little reading, and listening to that TED talk by B Patterson. And I'm a fucking carpenter and artist... but I can/could at least follow the science).
I'm going for the idea that 2 BTDs are in the offing... First one for combining LL with the SOC (Bev/Taz in mCRC). That will de-risk LL for Roche... and let them up the price on Avastin as part of a newly patented triplet SOC for 3rd-line mCRC IMMEDIATELY... Or very soon. The more significant BTD would be for LL priming, and an ICI to finish the job. Probably happens later... But this two-stage BTD looks like the best and most probable outcome for Cytodyn... and cancer patients.
556 words without a mention--not a word--about what indication the BTD is for? Kinda lame if you ask me...
What are the implications of a BTD for a new LL/Bev/ Taz combo, vs a BTD for an ICI/LL combo? I would say it is a rapid AA for the triplet as the new SOC... and a slower process for the LL/ICI combo. And that is acknowledging the deliberate pace of the FDA in terms of novel drugs. So the easy path is to approve a BTD for the new SOC, while leaving room in the near future for the real radical explosion of efficacy that LL and an ICI apparently provides. (And another BTD!). "Apparently" is the key word here... while there are signs that the new FDA will rapidly move forward with novel cancer drugs that provide substantial benefit, they might have some problems understanding a multi-purpose immune modulator that actually works... and can exert it's therapeutic effects based on homeostasis (thank you Ohm) vs single MOAs like cancer-killing chemo or checkpoint inhibition. Like they can't get there head around a well-designed CCR5 inhibitor (thank you Paul Maddon) that performs way way better than maraviroc or the other CCR5 inhibitors that have been tested. Stupid fucks... (Unless they surprise me and move Leronlimab forward... I will humbly take it all back if they get their shit together!). But--can the RFKjr FDA get their heads into this? Ideology may get in the way here--there are a large number of failures with less-than-optimal CCR5 inhibitors. So saying "Prove It!" is not unreasonable. Lalezari is hell-bent on doing just that... and he is nothing but thorough. Like 35 years or so as head of a CRO that has worked with a variety of Big Pharma companies proving through well-designed trials whether their drugs work or not. It's not that his credibility is on the line... It's that he has earned his credibility.
(Jeff Fucking Murray may not agree--but the outing of his treatment of Cytodyn during the Covid crisis will bite his ass--and reputation--sooner or later. The history books will put a million or so lives on his mean-spirited, vile decisions when the world needed him to be open-minded and insightful about what kills severe covid patients--the over-reaction of the immune system, the cytokine storm... not the virus! Covid--like cancer--is a RANTES disease! Jeeze, even I could see that/learn that. After a little reading, and listening to that TED talk by B Patterson. And I'm a fucking carpenter and artist... but I can/could at least follow the science).
I'm going for the idea that 2 BTDs are in the offing... First one for combining LL with the SOC (Bev/Taz in mCRC). That will de-risk LL for Roche... and let them up the price on Avastin as part of a newly patented triplet SOC for 3rd-line mCRC IMMEDIATELY... Or very soon. The more significant BTD would be for LL priming, and an ICI to finish the job. Probably happens later... But this two-stage BTD looks like the best and most probable outcome for Cytodyn... and cancer patients.
556 words without a mention--not a word--about what indication the BTD is for? Kinda lame if you ask me...
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