Posted by C on YMB: Remdesivir in India - Top story of the week - India's medical elite announced it is or maybe ending Remdesivir as a COVID 19 remedy due to poor performance. Days ago, Macleods announced a 3 year exclusive agreement with CytoDyn for Leronlimab in India. The timing of these announcements can not be ignored. Macleods has a very large presents in India and as such knows the inner working of the Indian medical system. They have followed the progress of Remdesevir and Leronlimab with the FDA. Macleods came to the same conclusions many of us have
1] Leronlimab is very safe
2[ Leronlimab, if allowed 4 injections on a weekly basis vs 2 as was dictated by the FDA trial, results would have met required end points.
3] Leronlimab can be safely injected out of Hospital setting so it can reach its population.
The FDA letter that just posted and the timing of that letter are revealing. The content of the letter tells us what we already knew - we failed endpoints based on the trial parameters set by the FDA - 2 injections a week apart. Who was on the decision made by 3 people that forced the 2 injection limit - a Doctor "related" to Gilead. Who objected to the 2 injection limitation? Dr. Jay Lalezari who is a leader in HIV and has extensive knowledge of Leronlimab and COVID. The FDA letter also promotes that they will work with CytoDyn on further trials. I believe that is their primary task. Thank you US FDA.
Conclusion - Macleods has game on. Gilead has a problem. FDA is using the letter to save face. Once out of the US, the US FDA has clout but not control over use. India is proof. CytoDyn made the necessary move to advance Leronlimab for its patients, for its shareholders. Its game on and I am all in.
