What narrative was I trying to fit? I was excited about the data on all twelve patients which was great and far above your expectations. Nor was I hoping that the treatment had a preferred subset. . In most trials, there is an attempt to identify subsets of patients for which the treatment has the greatest efficacy. The subset of patients having a greater number of prior year surgeries in this trial has a dramatically better chance of a CR which is statistically significant. This subset was not a biased selection of individual patients as you ignorantly claim.
In terms of timing, the FDA may need to see more than 6 months data on the majority of Phase 2 patients because all patients in Phase 1 went more than 5 months without surgeries and it may take longer to identify CR's.
I believe you and others are ignoring the costs and dangers of surgeries and Avastin on these patients.
Below is part of a Statement from Dr Baker at Johns Hopkins, most likely the leading RRP specialist in the country, particularly with IV Avastin at the RRP.FDA listening in September 2022
Forum in SQ: What would be a meaningful reduction in the number of surgeries, as it seems to vary widely?
A: There was a consensus from the patients and caregivers that any reduction in the number of surgeries would be impactful. Individual responses are summarized below. ” Dr Simon B: “If I could just say as a surgeon here, the correct answer to this question is one. Right, there’s no other correct answer. Any surgery to the vocal cords is traumatic, any surgery for papilloma carries with it the risk of a lifelong of permanent vocal damage. That was the point of what I was trying to say about the way that our vocal cords function and the way that they vibrate, the way that they produce sound, is completely irreplaceable. There’s no other treatment option, there’s no stem cell treatment that is going to recover vocal cord scar once it has occurred. So really any surgery they can avoid. One surgery over the course of someone’s life is worth it because that reduces the risk of permanent vocal cord damage and that’s a lesson that every surgeon who operates on vocal cords would confirm.” .
