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Re: None

Tuesday, 05/26/2020 8:02:31 PM

Tuesday, May 26, 2020 8:02:31 PM

Post# of 721591
https://www.regulations.gov/docketBrowser?rpp=50&po=0&dct=PS&D=FDA-2019-D-4964

I scanned thru the about 68 comments posted in the dockets under the Effectiveness of Efficacy guidance that FDA is going to publish in the FR any day; almost 99% of the comments support this guidance document. While the comments are mostly positive, I think FDA is going to wrap it up fast and issue the final guidance in the FR any day now. And that means DCVaxL approval is already in the bag, imo.
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