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Posted On: 02/21/2020 2:49:56 PM
Post# of 148902
Sjacobs,
Yup, this is the beauty of a basket trial imo. We will have several shots at different indications. If we could tell FDA "look there where tumor reductions of xxx and yyy magnitude in BC, Colon Cancer and Lung Cancer and the patients are doing well after zzz time" they will be thinking more in the lines of: "Ok, how are we going to design a quick trial to validate Leronlimab for BC Colon and Lung and continue validating for all those other indications", rather than saying: does Leronlimab work ?
I was also pleasantly surprised by the speed at which this was granted !!!. FDA always thinks on safety and it would appear that they have already understood that Leronlimab is safe. Any other company would have had a hell of a time getting the basket trial reviewed this fast !!, NP suggested this only few weeks back. So, you are absolutely right it is a huge advantage. Frankly, is probably unheard of.
Will it work for all 22+ indications?? Difficult to say, maybe we will find out simply that works better in some than in others (here I am talking out of the understanding, or lack of, that cancers are very different entities with heir own complex "identities" to put it in some way, however the fact that it has been effective in, for example, glioblastoma would indicate that the MOA is very general.)
In any case, good effectiveness in only one indication would be a huge achievement. And I believe we crossed that bridge long time ago with mTNBC.
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I fully expect the MOA to be proven as it has shown in 100% of the patient results publish thus far.
Yup, this is the beauty of a basket trial imo. We will have several shots at different indications. If we could tell FDA "look there where tumor reductions of xxx and yyy magnitude in BC, Colon Cancer and Lung Cancer and the patients are doing well after zzz time" they will be thinking more in the lines of: "Ok, how are we going to design a quick trial to validate Leronlimab for BC Colon and Lung and continue validating for all those other indications", rather than saying: does Leronlimab work ?
Quote:
I haven't looked, but I doubt any of those other drugs are nearly as safe as lerolimab, so that is a huge advantage for CytoDyn even without unbelievable efficacy and high responder rate.
I was also pleasantly surprised by the speed at which this was granted !!!. FDA always thinks on safety and it would appear that they have already understood that Leronlimab is safe. Any other company would have had a hell of a time getting the basket trial reviewed this fast !!, NP suggested this only few weeks back. So, you are absolutely right it is a huge advantage. Frankly, is probably unheard of.
Will it work for all 22+ indications?? Difficult to say, maybe we will find out simply that works better in some than in others (here I am talking out of the understanding, or lack of, that cancers are very different entities with heir own complex "identities" to put it in some way, however the fact that it has been effective in, for example, glioblastoma would indicate that the MOA is very general.)
In any case, good effectiveness in only one indication would be a huge achievement. And I believe we crossed that bridge long time ago with mTNBC.
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