Thank you TechGuru, always appreciate your perspective. And I agree with your statement, we should be able to do better than that.Quote:We should be able to do better than this easily.
It is interesting to note that the US government spent $450 million to procure 1.3 million doses of Regeneron's REGN-COV2 antibody cocktail one day after Regeneron announced the start of late stage trials. This is part of the government's "Operation Warp Speed" program.
Source Link: https://www.cnbc.com/2020/07/07/regeneron-sig...erapy.html
Quote:The agreement covers a fixed number of bulk lots that are intended to be completed in the fall of 2020, the company said.
It expects a range of 70,000 to 300,000 potential treatment doses or 420,000 to 1,300,000 prevention doses to be available from these lots, with initial doses to be ready as early as the end of summer.
If EUA or product approval is granted, the government has committed to making doses from these lots available to Americans at no cost and would be responsible for their distribution, Regeneron said.
Source Link: https://www.fiercepharma.com/manufacturing/re...y-cocktail
Quote:Monday, Regeneron said it would take REGN-COV2 into a phase 3 human trial as a possible preventive for novel coronavirus infections. The prevention study comes after a data monitoring committee's recommendation based on early data.
The drugmaker already started the cocktail in phase 2/3 human trials as a treatment for hospitalized and non-hospitalized COVID-19 patients. Those studies will aim to enroll nearly 3,000 patients across 150 sites in the U.S., Brazil, Mexico and Chile and will assess virologic and clinical endpoints.
It seems that CytoDyn has not registered for the "Operation Warp Speed" program and I can easily imagine some of the reasons why: they probably want to retain some control over pricing, distribution, and global allocation.
Additionally, with what we believe is a broad spectrum drug like lernonlimab, they probably also want to have some semblance of control over the indication(s) the therapy is being used for, assuming the possibility of one or more BTDs in the near future.
What's my point?
1. Contrary to previously posted information, the DSMC does NOT ONLY look at the safety of the treatment arm. It is a simple fact that the DSMC looks at efficacy and can make a number of recommendations, including terminating a trial due to overwhelming benefit. The DSMC can also make other recommendations, as can be seen the bolded text in the last quote. And I can only hope someone at CytoDyn communicates to the FDA or the government that no individuals currently receiving leronlimab have apparently contracted the virus.
2. The US government should have already made overtures to buy all of the available inventory of leronlimab -- based not only on the M/M but also the DSMC's safety look at the S/C. Assuming CytoDyn has not yet made the M/M trial data available to the FDA or the government, I have to assume that discussion will happen no later than this week. And that discussion should be happening even if the FDA demands a Phase 3 M/M -- after all, the government bought all of Regeneron's cocktail a day or so after trials started. We're way past that.
I agree with your astute quote of: "We should be able to do better than this easily" -- but if the US government does not purchase the entire available inventory of leronlimab based on our trial data, then: "Houston, we have a problem."
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