-
How do you feel about the news of Vatiquinone’s approval being denied?
Recently, there was a press release that the FDA rejected PTC Therapeutics’s request for the drug, Vatiquinone, and its approval for FA. The FDA stated in the Complete Response Letter that substantial evidence of efficacy was not demonstrated for Vatiquinone and that an additional adequate and well-controlled study would be necessary to support the resubmission of the New Drug Application.
This news was devastating to many in the community because it would have been the second treatment for adults and the first treatment for children with FA.
How did hearing this news make you feel, and are you feeling positive or negative about the future?
For more information on the press release, please click below:ir.ptcbio.com
PTC Therapeutics Receives Complete Response Letter for Vatiquinone NDA | PTC Therapeutics, Inc.
The Investor Relations website contains information about PTC Therapeutics, Inc.'s business for stockholders, potential investors, and financial analysts.
-
0 Replies
Sorry, there were no replies found.
Log in to reply.