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Re: MFS post# 11944

Monday, 04/23/2018 1:10:49 PM

Monday, April 23, 2018 1:10:49 PM

Post# of 44784
At least we finally have a definitive answer as to where we are headed with the product... and, thankfully, we do not have to pay for the research... the first year data will provide the protocol for the pivotal study as agreed to with the discussions with the FDA... it certainly is not the timeframe we all expected but, IMHO, the filing should be pretty close to early 2021... in the meantime, we have the IC data close to readout and lets hope we have reason to celebrate because positive results there will extrapolate to the ARS and other indications....