The next FDA window isn't two years away. Andy can submit another 510(k) anytime he wants. Not saying it would get cleared, but all the company has to do to placate shareholders and noteholders is keep up the appearance. One of the following has to logically be true about that last 510(k), IMO:
* The company knew that 510(k) was doomed to fail, but wanted to keep up appearances;
OR
* The company has no clue about what the FDA wants to see in a 510(k) or how to get the FDA's help. Who knows what they told the FDA in those pre-submission meetings!
Either way, I think another 510(k) submission is coming sooner, not later.
A third theory is that the FDA lied to the company because Big Pharma is scheming against the company. Conspiracy Theories like that appear every time a biotech gets a 510k) rejected. I don't buy it. "Big Pharma" is a fictitious entity -- Biotech is a business and the big pharmaceutical companies COMPETE, not COLLUDE. If a big company like J&J thought the ActiPatch was such a great moneymaker they'd buy it, not squash it. Even if IBEX and St. John's called in their loans as part of a sale, it wouldn't take much $$$ to buy out this tiny company.
The problem is, the ActiPatch was a dismal failure in the UK, so companies like J&J won't act until they see some proof that the ActiPatch is a moneymaker. Revenue spikes like the Dr. Oz Phenomenon and the UK "Trial Version" showed that consumers are curious, but the lack of subsequent sales raises huge question marks for companies like J&J.
I think the ActiPatch OTC 510(k) gets cleared someday, but not with clinicals that have the Konerus or Eppley as PI. Somebody at BIEL is smart enough to see this. So how does the company get some independent researchers to conduct ActiPatch trials? THAT should be the company's focus.
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