RE: MOTIF sp NASDAQ8 Jun 2019 09:36
People here are understandably very angry about this situation and are gunning for the CEO, the trolls are having a field-day as the company appears in disorder. I am sitting on a large paper loss, as I am sure the majority of holders are. Just to throw in some balance, the trial protocol was blinded and agreed with the FDA and so the observation of the prolonged elevated levels was unexpected. The CEO may have put forward arguments post the CRL follow up meeting, to try and convince the Agency to allow a post approval study. The company may not have got the response that this was not acceptable until it was included in the minutes, several people here are making the assumption this was discussed at the meeting and that option rejected at the meeting, implying that the CEO is withholding the truth. This may not be the case! The FDA are also a guiltily party here, they are the gatekeeper, but are also supposed to help and partner with companies to achieve approval. If a company follows their agreed protocol and the data and the study appears successful, then the company will have been expecting that the approval is a formality. I think that’s what may have happened here. I understand the frustration and the anger here placed at the CEO, this is why he gets paid the big bucks. But now is the time more than ever, for him to earn his keep. Let’s see if he can get the funding we need, realise the potential and value of this asset, gain approval and realise this treatment for suffering patients. Good luck to all, JB