Bingo, Dewey is right, the FDA
has changed significantly over the last year. We will find out soon enough.
They have already done their homework on this product. NOT NEW to them.
The current study should be supplemental to the previous studies.
It should "piggyback" as it is substantially equivalent.
Biel in the FDA May 9th Meeting goes something like this.
Biel: NHS is paying for these now, you saw their study right?
FDA: umm, yeah we know, and their study is impressive.
Biel: Pretty impressive results for the back study ehh??
FDA: umm, yeah.
Biel: Great alternative to opioids you know right?
FDA: Umm, yeah we know.
Biel: Any reason we can't announce clearance is done and granted today?
FDA: Umm, that would mess up our bureaucratic nightmare thing we have going.
Biel: Oh, ok what do you need 2 week, 4 weeks?
FDA: uhh, uhh, well uhh,
Believe me, I fully understand bureaucracy.
We are going to find out soon enough. FDA bureaucracy as usual or the new FDA.
In either case fast or short time till FDA clearance, BIEL has its hands full developing
95% of the worlds market outside of the USA.
USA however does represent 25% of the worlds purchasing power.
I said months ago 2-4 weeks after the meeting. If I am wrong, that is fine. It will happen soon enough.
We are fine with the 75% until------
wait for it---------
wait for it-------------
wait for it-----------------
THEN!!
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