Questionable trial -- Complete redo of the trial protocol, endpoints, comparator AFTER the interim analysis and two weeks before the data lock. ECA along likely ended their chances with the FDA as FDA Guidance is for ECA to be designed, completed and approved by FDA BEFORE the trial is initiated. FDA rejected it and now MHRA is taking a looooong time and likely several RFI's before they will make a decision. Notice investors are questioning the future as share price has been down significantly even with stock pumping pumping an "approval" to pump the stock.
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