I don't have the checklist of all the things that need to be done properly to gain approval in August. Nor did I when an inspection was required prior to their first approved product. Point is, anecdotally I could make the case that based on a long history of decision making snafus, management isn't good at dotting and crossing. Ergo it's more than possible that they get bitten again
PS - yes there has been dilution but to the average shareholder it's been a rough road. Prior to any approval the stock price has been at or near these levels going back years. Now on the precipice of a historic therapeutic approval she's stuck in neutral just 2 months prior?