Good post, Sherlock. You discussed Jay's mention of Breakthrough Designation toward the end of the video, wondering which indication and even which combination of drugs it might be for. Casrai's website, a reference site, offers a good bit of info about the BTD process here: https://casrai.org/guides/fda-breakthrough-th...esignation . They write:
Since Jay talked to the FDA this summer, there is no recent TNBC data or LL + ICI he could have given them; he surely presented information from the CLOVER data, with Leron plus the Bev/Taz combo. I think the BTD application must be for CRC with that combo.
I'm still a little nonplussed, because he said they'd apply by the end of the year. The BTD application is 20 to 50 pages, requiring clinical evidence showing "substantial evidence over existing therapies" and "unmet need," which for CRC shouldn't be difficult. It should not take nearly three months to put this together. One estimate I saw was a month to six weeks to assemble the package. A month would actually bring a reply before the end of the year. I don't see why Jay et al shouldn't manage to do this on a normal time span.
Quote:Eligibility criteria
FDA applies two conjunctive criteria: the drug must be intended to treat a serious condition, and preliminary clinical evidence must indicate that the drug may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint
Since Jay talked to the FDA this summer, there is no recent TNBC data or LL + ICI he could have given them; he surely presented information from the CLOVER data, with Leron plus the Bev/Taz combo. I think the BTD application must be for CRC with that combo.
I'm still a little nonplussed, because he said they'd apply by the end of the year. The BTD application is 20 to 50 pages, requiring clinical evidence showing "substantial evidence over existing therapies" and "unmet need," which for CRC shouldn't be difficult. It should not take nearly three months to put this together. One estimate I saw was a month to six weeks to assemble the package. A month would actually bring a reply before the end of the year. I don't see why Jay et al shouldn't manage to do this on a normal time span.
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