Thursday, December 05, 2019 2:53:19 PM
Exactly. The point is that FDA could have EASILY approved the 525 mg dosage with the condition of post-approval optimization (it happens all the time).
Look at DVAX approval of Heplisav-B (Hepatitis B) that demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B. They required lots of post-approval follow up, but approved the vaccine in spite of all the AE's.
FDA could have approved Leronlimab and told the company: Follow up your 525mg patients and launch a second trial with higher dosage with naïve and/or migrated patients.
This, much easier granted the demonstrated safety of the drug (0 SAE's), and, even better with CTC counts and/or occupancy tests.
But, no. They decided to subject an economically unstable company to the burden of a significant delay just to keep them happy.
You are absolutely right. Couldn't have said it better.
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