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Re: DeepDive post# 1972

Wednesday, 05/13/2015 2:50:28 PM

Wednesday, May 13, 2015 2:50:28 PM

Post# of 3833
Adi2: IMO the type of chemical characterization data that FDA requested from La Jolla is typical for entering phase 1 human trials. La Jolla's intent was to enter phase 1 with an orally active derivative of GCS-100. Therefore they were required to submit chemical characterization information for the new derivative. GALT is now entering phase 2 (multiple trials) so it is evident in my opinion that they have already submitted the required chemical characterization for GR-MD-02 and from the FDA approving the two new trials posted on clinicaltrials.gov it does not appear to me that there is an issue. ALL IMHO
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