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Message: Re: Breakthrough Designation
2
COX
May 28, 2020 12:40AM

COX
May 28, 2020 01:16AM
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May 28, 2020 07:36AM

COX – It appears that when you search on the FDA site that you don’t always get everything. I found another approval linked below. The numbers also don’t add up well from report to report. There were 9 BTD approvals in Oct./Nov./Dec. 2019 so along with the 5 you found in 2020 plus the extra one I found, that totals 15 since Oct. 1/19 to the data date of March 31/20. The second link below shows BTD requests since Oct.1/19 and the data date again is March 31/20. There it says 17 have been granted. We probably have to assume that the Apabetalone approval is at the FDA somewhere but we just haven’t figured out how to find it yet.

https://www.fda.gov/media/95286/download

https://www.fda.gov/media/95944/download


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