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Re: apostle1313 post# 1404

Saturday, 11/22/2008 9:27:40 AM

Saturday, November 22, 2008 9:27:40 AM

Post# of 11073
Sounds to me like someone (although I'm not going to mention any names, but his initials begin with Dr. David Phillips) needs to get crack-a-lackin' on a PMA or 510K for FDA approval. If he has poured all that energy into R&D and performed clinical testing, etc, then why hasn't he submitted FDA forms for it? I am still asking myself why he hasn't elected to have his financials independently audited and submitted to the SEC so his stock prices are more attractive.....but that's another story.
There is alot I don't understand about the FDA. I do know that it takes FOREVER for the FDA to approve regulated products ESPECIALLY medical devices and drugs. If Dr. Phillips submitted a request, it may take YEARS of clinical research and proof for the FDA to accept the claim.(Because everybody knows the pharma company lobbyists have a big baseball bat to swing when it comes to influencing the FDA. Heaven forbid an alternative comes along and takes money away from the giant pharma companies. The term 'legal organized crime' comes to mind.)
With that being said, RBRM should have filled out one of those FDA things a LONG time ago. At least the process would be in motion. Nobody can tell me they were not aware of this hitch. The possible good news is that RBRM already has alot of clinical data so it's not like they are starting from square one.