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Posted On: 11/06/2023 9:49:41 AM
Post# of 148878
On March 11th, 2020 Dr. Lalezari emailed Jeff Murray (FDA Deputy Director of the Division of Antiviral Products) about Covid-19 trials using leronlimab and the protocols. His response -
It seems like the fix was in for remdesivir quite early. At least someone at the FDA knew leronlimab's safety.
When the data from the Covid-19 patients at Montefiore became available Dr. Lalezari sent it to Jeff Murray. I'm sure he also outlined the mechanism of action. Part of his response -
Does Murray know so little that he only knows CCR5 in the context of HIV? It seems like the FDA mainly consists of bureacrats who have little knowledge of science and will avoid obtaining any.
PS. Jeff Murray left the FDA and became an advisor for Exavir Therapeutics who's main area is HIV.
Quote:
As an investigator, why would you choose this drug rather than be involved with either the NIH or Gilead remdesivir trials? Remdesivir has decent in-vitro activity against SARS CoV-2, one of the few drugs tested so far. What compelling non-clinical data support the use of leronlimab for COVID-19 over other drugs that have been prioritized? In addition we are not enthused about single arm trials or compassionate use for products that don't have good evidence of activity nor for drugs that might have unfavorable toxicity profiles (the latter is not the case for leronlimab).
It seems like the fix was in for remdesivir quite early. At least someone at the FDA knew leronlimab's safety.
When the data from the Covid-19 patients at Montefiore became available Dr. Lalezari sent it to Jeff Murray. I'm sure he also outlined the mechanism of action. Part of his response -
Quote:
"In my opinion, leronlimab didn't have the type of compelling nonclinical rationale to give me a strong Bayesian prior, so it will take a lot more than a series of 7 patients (who did not fit the definition of critically ill) to change my opinion.
Does Murray know so little that he only knows CCR5 in the context of HIV? It seems like the FDA mainly consists of bureacrats who have little knowledge of science and will avoid obtaining any.
PS. Jeff Murray left the FDA and became an advisor for Exavir Therapeutics who's main area is HIV.
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