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Posted On: 04/13/2020 9:44:15 AM
Post# of 148908
“Also, recruitment for the Mild to Moderate P2 is ongoing full speed in Montefiori and we have already 12 patients as last week.”
This enrollment speed is far too slow for both trials. Last Monday we got a PR that said the first 2 patients in the mild/moderate trial had been enrolled. The Novant health PR came out 2 days later, but somehow we only enrolled 10 patients in a week? Maybe Novant isn’t enrolling patients yet and is still approving the protocols at the administration level? NP said two weeks ago that doctors told him they could fully enroll the trial in one day, but here we sit, waiting for administrations to approve the trial. Either way, enrolling 10 patients in one week for the mild/moderate trial and zero into the severe trial isn’t helping our cause. Dr. Kelly needs to step in ASAP and get these trials moving.
“And, mark the date for recruitment of P2b/3 Severe enrollments.”
We need data from 50 patients for at least 2 weeks before the preliminary review can be done. Hopefully the first clinical site that was approved to enroll patients is a large site and can enroll quickly.
“Just great news to start a very eventful week.”
I hate to bring up a dead horse we’ve beaten over and over, but NP needs to get the BLA submitted. This COVID19 indication is taking much longer than expected to evaluate and the company is no doubt burning serious cash. Combo therapy for HIV is the only indication that is nearly guaranteed to bring revenues and the BLA continues to be delayed, with COVID19 as the current excuse. CYDY knows how the FDA operates and based on their history, the FDA is not likely to approve leronlimab for COVID19 without proper data (emergency approval from 7 patients is unlikely). Therefore, as much, or more effort, should be out into filing the BLA.
This enrollment speed is far too slow for both trials. Last Monday we got a PR that said the first 2 patients in the mild/moderate trial had been enrolled. The Novant health PR came out 2 days later, but somehow we only enrolled 10 patients in a week? Maybe Novant isn’t enrolling patients yet and is still approving the protocols at the administration level? NP said two weeks ago that doctors told him they could fully enroll the trial in one day, but here we sit, waiting for administrations to approve the trial. Either way, enrolling 10 patients in one week for the mild/moderate trial and zero into the severe trial isn’t helping our cause. Dr. Kelly needs to step in ASAP and get these trials moving.
“And, mark the date for recruitment of P2b/3 Severe enrollments.”
We need data from 50 patients for at least 2 weeks before the preliminary review can be done. Hopefully the first clinical site that was approved to enroll patients is a large site and can enroll quickly.
“Just great news to start a very eventful week.”
I hate to bring up a dead horse we’ve beaten over and over, but NP needs to get the BLA submitted. This COVID19 indication is taking much longer than expected to evaluate and the company is no doubt burning serious cash. Combo therapy for HIV is the only indication that is nearly guaranteed to bring revenues and the BLA continues to be delayed, with COVID19 as the current excuse. CYDY knows how the FDA operates and based on their history, the FDA is not likely to approve leronlimab for COVID19 without proper data (emergency approval from 7 patients is unlikely). Therefore, as much, or more effort, should be out into filing the BLA.
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