Acer Therapeutics: Despite Receiving A Devastating CRL, The Story Isn't Over [Seeking Alpha]
Acer Therapeutics Inc. (ACER)
Last acer therapeutics inc. earnings: 3/18 04:05 pm
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Source: Seeking Alpha
Acer Therapeutics: Despite Receiving A Devastating CRL, The Story Isn't Over Acer Therapeutics Inc. ACER Before markets opened on Tuesday, June 25, Acer announced The type of trial being requested by the FDA in its CRL would take many years (if not a decade or more) to complete and would be a very difficult type of trial for which to recruit patients. Not only is the population of vEDS patients very small, but what a vEDS patient would want is to volunteer to participate in a clinical trial that could go on for years knowing that he or she had a 50% chance of being given a placebo! If the FDA is not persuaded to change its mind and Acer is required to conduct such a trial before approval of EDSIVO, I doubt that it will do so. Quite frankly, the CRL issued by the FDA and its trial requirement is a disaster for the U.S. vEDS community, Acer Therapeutics and its shareholders. Given how well-known the safety and long-term data from celiprolol (EDSIVO) is relating to the treatment of vEDS,
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