SC: My compliments for an excellent post -- well written, well reasoned, and brimming with an aura of confidence, born of considerable expertise on the subject of FDA timelines to approval. Clearly, your addition to the board should benefit all of us, especially since ohm doesn't post that often anymore.
So I'm setting my clock for a possible LL accelerated approval, if everything related to the CRC trial goes swimmingly, for late 2028, with the understanding that, because accelerated approval "cuts off 3 to 5 years" from the standard approval process, if the CRC trial surrogate endpoint data related to ORR and DOR isn't up to snuff, the approval clock needs to be pushed back to sometime between late 2031 and late 2033. So LL's first approval may well be almost 8 years away. Oh my! That's definitely not good news foe me as a CYDY shareholder since I doubt 80 year old men have an 8 year future life span. More importantly, a late 2033, or even an optimistic late 2028, approval date wouldn't be good news for the tens of thousands of patients battling mCRC.
Given the above historical FDA approval timelines, I can only hope that Dr Makary, and perhaps his Commissioner's National Priority Program, can make a dent. He does keep issuing public statements to the effect that he intends to speed up the approval process. I suppose time will tell.
I do, and for several months have, concurred with you that demonstrating pd-1 elevation in the CRC trial and thereby enhancing big pharma attention are of utmost importance to BO or partnership prospects and the share price. But I also continue to believe that the agreed payment terms for either partnership or BO will be significantly affected by whether the involved BP are expecting the initial LL approval (whether accelerated or standard) to occur in late "26, late "33, or wherever in between. I believe this based on the impression that BPs are often motivated by an interest in revenue, and that receiving revenue in "27 would seem preferable to receiving it in "34 (or perhaps never due to intervening events, both foreseeable and unforeseeable).
Consequently, while FDA approval history apparently is definitely on neither LL's nor mCRC patients" side, I will place my hopes (I know - never a good strategy) on Dr Makary to speed the good ship Leronlimab to open waters far closer to January 1, 2027 than January 1, 2034 if interim ORR and DOR data are paradigm changing.
So I'm setting my clock for a possible LL accelerated approval, if everything related to the CRC trial goes swimmingly, for late 2028, with the understanding that, because accelerated approval "cuts off 3 to 5 years" from the standard approval process, if the CRC trial surrogate endpoint data related to ORR and DOR isn't up to snuff, the approval clock needs to be pushed back to sometime between late 2031 and late 2033. So LL's first approval may well be almost 8 years away. Oh my! That's definitely not good news foe me as a CYDY shareholder since I doubt 80 year old men have an 8 year future life span. More importantly, a late 2033, or even an optimistic late 2028, approval date wouldn't be good news for the tens of thousands of patients battling mCRC.
Given the above historical FDA approval timelines, I can only hope that Dr Makary, and perhaps his Commissioner's National Priority Program, can make a dent. He does keep issuing public statements to the effect that he intends to speed up the approval process. I suppose time will tell.
I do, and for several months have, concurred with you that demonstrating pd-1 elevation in the CRC trial and thereby enhancing big pharma attention are of utmost importance to BO or partnership prospects and the share price. But I also continue to believe that the agreed payment terms for either partnership or BO will be significantly affected by whether the involved BP are expecting the initial LL approval (whether accelerated or standard) to occur in late "26, late "33, or wherever in between. I believe this based on the impression that BPs are often motivated by an interest in revenue, and that receiving revenue in "27 would seem preferable to receiving it in "34 (or perhaps never due to intervening events, both foreseeable and unforeseeable).
Consequently, while FDA approval history apparently is definitely on neither LL's nor mCRC patients" side, I will place my hopes (I know - never a good strategy) on Dr Makary to speed the good ship Leronlimab to open waters far closer to January 1, 2027 than January 1, 2034 if interim ORR and DOR data are paradigm changing.
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