Dr. Lalezari:
Quote:Question: And so, in your opinion, when to expect a preliminary approval for Leronlimab in this novel covid-19 indication?
Answer: Right, so I think the FDA is in a bit of a quandary here: And we are in a morally perilous place. I think it's impossible for a reasonable mind to look at some of this, the lab for data, and the clinical data and not conclude the drug is working.
Unfortunately there were delays in getting the clinical study started, I don't think the agency took this treatment modality seriously and that unfortunate they put us to the back of the line, and it was made a little worse, I think, by all the noise that our president was making about Hydroxychloroquine, at the end about a study done, a non-randomized study was very selective outcomes that most scientists regard as relatively meaningless, but the president was pushing that … inevitable that ended up putting pressure on the FDA and they issued some emergency approval for Hydroxychloroquine a drug that has known significant toxicity and down side and, partly because of that, and because of all the other companies who are vying to buy for their attention, the FDA really put Leronlimab in the back burner and, so unfortunately, we have fairly compelling though anecdotal data from the emergency IND experience without having yet enrolled a randomized clinical trial.
Obviously if the clinical study should have been able to start even a couple weeks earlier then, we'd be at this juncture where we had this exciting data from the ICUs and we could have had now I have enrolled clinical studies.
That creates a quandary for the FDA is what they're going to do about this we're obviously looking at a huge number of people dying in the US and around the world every day right now, I think that some sort of emergency conditional approval makes sense but I do not know what the regulatory answer is here. You know, I love randomized placebo-controlled double-blinded data as much as anybody else I wish we had it, but we're at a juncture where we don't have it but we have data that you can look at an even those anecdotal, when you tie the clinical outcomes and laboratory data together is very difficult to conclude that the drug is not working.
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