James C. Shehan is quoted in the Pink Sheet regarding Sarepta Therapeutics Inc.’s decision to not publicly disclose its submission of a formal dispute resolution request appealing the FDA’s rejection of the drug Vyondys 53. Shehan notes that the legal standard for determining whether information such as this must be disclosed is how material is it to an investor’s buy or sell decision and that, because companies don't often win formal dispute resolutions with the FDA, Sarepta’s decision to not disclose the appeal’s existence could be legally permissible. (subscription required to access article)