“I don’t think NP would have filed for BTD in the first
“I don’t think NP would have filed for BTD in the first place without encouragement to do so from the FDA.”
I find it hard to believe that the giant, bureaucratic FDA reviewed the initial data from 2 patients and replied with a, “Yeah NP, send that BTD over.” That would imply that the FDA reviews ALL pre-BTD applications and asks the companies with promising data to send their complete packets forward. That would also indicate that all BTDs should be approved because only those companies the FDA contacted would send their applications in. But we know that companies do get BTDs denied, so the whole idea that the FDA reviewed leronlimab data prior seems unlikely.
And I’ll remind you that NP read an email from the FDA last year (in the summer?) that said something along the lines of, “We (the FDA) want to get leronlimab to the market for HIV.” He was very proud of that statement, but here we sit, with our perpetual BLA delay which is apparently due to the “helpful” FDA.
I guess we’ll find out on the 5th, but NP promising an update on the BTD doesn’t sound promising I.e. the FDA responded and wants more data (sound familiar?). But I do acknowledge that NP does like to share new and exciting news during these CCs, so it’s possible he announces the BTD, although I’d prefer a morning PR.
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