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Re: Fordman65 post# 60983

Saturday, 01/14/2017 6:27:55 PM

Saturday, January 14, 2017 6:27:55 PM

Post# of 144814
I am a believer in this company...

however I do believe that it is very unlikely that they give the ok without any changes to trial design ( option 1)

Option 2 - is the most likely in my opinion... a few tweaks and recommendations to the trial design

Option 3 - back to phase 1 ... is a possibility but I believe it is very unlikely.... as unlikely as option 1.... many drugs have been approved with very old phase 1 data... and remember we are not testing a drug but rather the bioinert membrane ( the delivery method for an already approved drug) this alleviates much of the patient safety concerns that are often the cause of the FDA reverting back to phase 1 when the data is old
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