Posted On: 07/05/2016 11:48:56 AM
Post# of 72446
Interesting to note that the guy who has taken credit for creating this blog, Joseph Gulpto, posted in the comments the following:
"January 20, 2015
I have written a book about developing new medical breakthroughs, obtaining FDA and Europen approval, and getting them on the market – see http://www.innovationbreakdownbook.com/. To answer your questions more specifically – (1) Kevetrin is in Phase 1 – if the data are favorable, I believe that the quickest time to FDA approval is 4 years;"
So assuming that he has done credible research and has lots of industry data supporting the information in his book, the rough estimate for K FDA approval will be 2020 at the earliest. I base that on the trial having been completed at the end of last year, and data submitted to FDA in early 2016. That seems to fit right in with the overall 7-10 year development timeframe others have estimated before. Hopefully the orphan drug designation will expedite some of the FDA reviews and squeeze that down a bit, although it doesn't appear that it has so far.
"January 20, 2015
I have written a book about developing new medical breakthroughs, obtaining FDA and Europen approval, and getting them on the market – see http://www.innovationbreakdownbook.com/. To answer your questions more specifically – (1) Kevetrin is in Phase 1 – if the data are favorable, I believe that the quickest time to FDA approval is 4 years;"
So assuming that he has done credible research and has lots of industry data supporting the information in his book, the rough estimate for K FDA approval will be 2020 at the earliest. I base that on the trial having been completed at the end of last year, and data submitted to FDA in early 2016. That seems to fit right in with the overall 7-10 year development timeframe others have estimated before. Hopefully the orphan drug designation will expedite some of the FDA reviews and squeeze that down a bit, although it doesn't appear that it has so far.
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