Your concerns are legitimate. The mild/moderat
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(Total Views: 661)
Posted On: 06/03/2020 7:57:38 PM
Re: nmbr1stckpckr #36543
Your concerns are legitimate.
The mild/moderate trial will fully enroll, or nearly fully enroll, but the severe trial is at risk of not ever fully enrolling. I bring this up because there’s a chance that the FDA likes the phase 2 M2M trial data, but asks CYDY for a larger P3 trial (think remdesivir). If that’s the fact, CYDY will be forced to start a larger P3 in M2M patients UNLESS the interim analysis from the severe trial is outstanding and statistically significant. But the FDA could also ask CYDY to finish enrolling the severe trial as well, at which point CYDY will play the long game, which will be expensive and more difficult as COVID19 patients are more difficult to enroll as patient numbers are dropping and other trials are increasing.
July may be a great month or it could be a frustrating month. I don’t think at this point there’s a way to tell which direction it will go. I’m hopeful that NP, Dr. BP, and JL’s optimism materilzes.
But what I’ve said in the past is this: I’m primarily here for the cancer trials. There is no BP or other drug that can stop positive data from leronlimab I’m cancer from getting to the masses, especially breast cancer. If this goes back down to $1 because of difficulties with COVID19 approval, I’ll buy more because cancer is worth big money.
The mild/moderate trial will fully enroll, or nearly fully enroll, but the severe trial is at risk of not ever fully enrolling. I bring this up because there’s a chance that the FDA likes the phase 2 M2M trial data, but asks CYDY for a larger P3 trial (think remdesivir). If that’s the fact, CYDY will be forced to start a larger P3 in M2M patients UNLESS the interim analysis from the severe trial is outstanding and statistically significant. But the FDA could also ask CYDY to finish enrolling the severe trial as well, at which point CYDY will play the long game, which will be expensive and more difficult as COVID19 patients are more difficult to enroll as patient numbers are dropping and other trials are increasing.
July may be a great month or it could be a frustrating month. I don’t think at this point there’s a way to tell which direction it will go. I’m hopeful that NP, Dr. BP, and JL’s optimism materilzes.
But what I’ve said in the past is this: I’m primarily here for the cancer trials. There is no BP or other drug that can stop positive data from leronlimab I’m cancer from getting to the masses, especially breast cancer. If this goes back down to $1 because of difficulties with COVID19 approval, I’ll buy more because cancer is worth big money.
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