The FDA is pass or fail.....no in betweens......again, no one here can say we've submitted and here is where we (BMOD) stands with respect to the FDA...
It is up to BMOD to say, we've submitted, for this part we have satisfied the FDA for phase II and for the next phase we need to be more finite with our findings or mayby not and the findings may be good enough for the FDA and have satisfied phase II.
Yet no here has defined or established what the pass or fail criteria is for the submissions with respect to the FDA.....
Nothing that passes is 100% accurate....its either Pass or Fail with the FDA. Things fall into their (the FDA"s)own "margin or error" catogories. They make the judgement call, in their opinion, then we move on or redo.
NOW CAN YOU SAY WITH ANY ACCURACY OR BEING CERTAIN OF YOUR BELIEF WHERE ARE WE NOW......? Specifally with this past test...submitted or not? If you don't know thats ok, but please don't pump out uncertainties into the blog, either you know or you don't.
But no one here to date has specifically identified our statues?
Are we waiting to here from the FDA?
Meaning being, are we done with phase II or not? Did we pass phase II or did we fail? Do with have to resubmit on phase II or are we good enough now to move to phase III?
Can the Questions be any more direct or simpler?
Why does it matter? Because the answers to the above can help us/me understand where the price and volatility will be heading into the immediate near future. If they (BMOD) will need funding and how they will fund the company, either through the issue of more stock and or private placement of bonds?
Again, just my humble thoughts and opinions in my quest for the real no spin, no pumping or bashing truth.
Sashasees
AI
