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Re: TheRagman post# 10379

Thursday, 03/27/2014 6:12:15 PM

Thursday, March 27, 2014 6:12:15 PM

Post# of 12450
This was out on March 3rd;

"The companies previously reported on February 4, 2014 that they received the FDA's CRL which raised questions primarily related to third party Chemistry, Manufacturing and Controls (CMC) and to the packaging and labeling of the product. The FDA's CRL did not raise any questions or deficiencies relating to the anti-migraine VersaFilm(TM) product's safety and did not require additional clinical studies. IntelGenx and RedHill believe that their response to the FDA addresses all the issues raised in the CRL."

Based on this nothing seems to be wrong with the drug..once they clear this up we should hear some good news. Which should be anytime now...
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