People are wising up here...Many with extensive FDA and smallcap FDA experience have shared many times, about processes and steps. Only to be met with, the FDA clearance "any day" crowd. Hopefully, people will start to put this together. People like nopinkscam, yourself, fuente and others have shared valuable information, so you cant buy into the hype of any day anymore.
To add to GetSeriousOk's post...
The FDA has that 100 day response time, in their policy...Unless of course they ask questions. Then per policy, they can use the full 100 days again. One only hopes that, if they keep asking questions, it should be the bigger, harder, things that jump out right away, to finding smaller, easier, issues later, per responses, so you usually see the 100 day not being taken by every question, as time passes. But still can use that 100 if necessary.
But... As I, and some others have been trying to tell people, saying they went a wrong route on their 510K submission, requires a complete new submission. And as you so put it, doesnt need to use the word rejection, as its implied. I agree this will take the De Novo approach again, and that is going to be quite lengthy. Hitting a ton of debt conversions, dilution, maxing, and splitting, to even try that exact same De Novo approach, thats failed in the past.
BIELs update on "wrong route" starts this over again. Like it or not, thats how the FDA works. What folks should be questioning, is why so many blunders in the process, if you supposedly have the "so called FDA experts" handling this for you? This is basically starting over with a totally different company. An 11.1 Billion float(Float is always the O/S, RED FLAG), 15 Billion A/S one. Not anywhere near the same structure last time they filed a 510k or De Novo. Time is NOT on their side. Time is very costly to BIEL now.
And lastly, which Ive shared and echoed many times by a few on here, for some reason BIEL will just not do the trials necessary, that theyve been denied over, should have experts on staff to know about, yet avoid... etc etc etc.
Even if you want to be positive here. The 3rd Q Oxford trials, may still not satisfy any of this. But even if it does 50%. This will need a new submission, and takes this to end of 2017 at earliest, using that data from Oxford.
Before you pile into any more dips, people need to know exactly the mess youre buying into. As this plays out, .00x prices will seem like a long ways away to see again soon. Making many who continue to buy these levels, looking for delays, losses, more shares, and trips will be back and continue to slide, as people realize exactly what is happening here.
I saw Friday when dismal numbers came out, that FDA on Monday. ANYTHING to try and bolster anything to combat the selling seen Friday and sure to continue this week, as not all saw the numbers during work hours until they got home. I can assure EVERYONE its impossible for any type of FDA clearance this week.
