Gman, I am trying to enjoy a Caribbean vacation and the nonsense is getting the better of me. Would you please tell people this...
1. To file an NDA, a company has to pay a fee of $2.3 Million. You CANNOT file unless you pay. Negotiations on a fee waiver take time and, unless one is of another planet, we know the FDA and other governmental agencies work very little during the holidays. As I posted previously, during that time we should not expect anything to happen (whether implicitly or explicitly) between Elite and the FDA. Nonetheless, it is clear that Elite was not sitting on their hands. Rather than waiting for Santa, the management team that Nasrat so effectively constructed had worked through a fee waiver agreement. Once the waiver was agreed upon, saving the company $2.3 Million, then Elite could file the NDA. Which brings us to the next point...
2. In his statement, Nasrat said Elite is filing the NDA IMMEDIATELY. Thus, triggering the $2.5 Million payment from Epic.
3. The reality is the Elite coffers will benefit from a net of $4.8 Million. How can investors not recognize the impact? How many other firms have a higher p/s and no revenues, simply debt, and only one product in their R&D pipeline? Answer is...TOO MANY. This only enhances Elite's value to an acquirer. Which, for real investors, matters more than the daily fluctuations of the p/s.
4. Let's talk about the "sky is falling" because there is a delay of two weeks. Okay, a delay. Does it mean that the approval will be delayed? Before anyone answers, they need to understand that the variable nature of approval makes the two weeks moot. But more importantly, with a priority review, Elite will have the FDA's decision WITHIN 6 MONTHS. WHICH IS FAR SHORTER THAN THE 18 MONTHS it would take otherwise. Does anyone think that priority review was not negotiated? Seriously? BUT WAIT, THE KEY WORDING IS...WITHIN 6 MONTHS...that means it could be in April as easily as June. And, to that, a two week delay, justified or not, simply DOES NOT MATTER!!! Oh yeah because Nasrat and Elite have done all they could to get the NDA to that point, they and we shareholders can only wait for the FDA to decide.
5. And, finally, the noise about Nasrat not telling us about all of this is fundamentally flawed. To begin with, he has been criticized for saying too much and now some want to criticize him for saying too little. The truth is such comments lack touch with the realities of the business world. Not sure what some people do for a living, but there seems to be a lack of understanding about how business operates within the demands of the external/regulatory environment. Perhaps it is that we should not expect people lacking decision making experience to understand what goes on in the board room.
Now I am going to spend the rest of the day looking at the ocean, not the p/s, because I see the strategic direction Elite is heading and recognize the goals will be reached. PERIOD.
