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Posted On: 04/06/2019 12:43:05 PM
Post# of 154883
Here is an article talking about the FDA trying to streamline even the supplemental ones
https://ascopost.com/issues/december-25-2017/...dications/
Doing combo first has overcome the biggest hurdles for fast approval for cancer if we get very good TNBC data. Either NP or RP made the point at NobleCon, the FDA would not approve the cancer indication quickly if they hadn’t gotten this far with combo (in the CMO area, having 200M worth of product ready)
https://ascopost.com/issues/december-25-2017/...dications/
Doing combo first has overcome the biggest hurdles for fast approval for cancer if we get very good TNBC data. Either NP or RP made the point at NobleCon, the FDA would not approve the cancer indication quickly if they hadn’t gotten this far with combo (in the CMO area, having 200M worth of product ready)
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