Thanks for the post yankee - I had skimmed this when it was first put on iHub and generally got the drift as great news for BIEL in its pursuit of re-classification and approvals to permit OTC sales in the US. You say "PERFECTLY" at the start of your post regarding the fit of BIEL with the new thinking of the FDA - I agree with your take!
From your post, it jogged me, so I went back for another look and here are the 3 points in the FDA release that I think are key to BIEL and its pursuit of OTC sales approval applications.
If they don't fairly represent the BIEL situation with unemotional fairness then nothing will. BIEL did not prepare and release this information, nor have I. Other shareholders or bashers here on iHub didn't either and it's not a biased PR from a paid agency. It's the real deal, the FDA talking and I applaud them for their obvious shift in thinking to actually promoting publicly that they now believe there are other ways to deal effectively with the epidemic of pain in our country, other than drugs. This is a huge shift in philosophy and can only benefit BIEL. I believe that any other take is based on greed, gross stupidity, or embittered past employees or previous investors who feel jilted. Tell me I'm wrong, seems to me that any naysayer to this logic is twisted by something and should be embarrassed to continue to bash the company that can bring relief to so may, including family members of the bashers! As to bashing for the sake of bashing, that was then, this is now. Thank you FDA! Takes a big person and a bigger group to admit their mistakes. The FDA has chosen the high road, admitting nothing, which only prolongs controversy, and is only moving forward and I am grateful.
Extract from FDA release:
• Using the agency’s expedited review programs to advance development of new non-opioid medications to treat pain with the goal of bringing new non- or less-abusable products to market.
• Working with other federal agencies and scientists to advance our understanding of the mechanisms for pain and how to treat it, including the search for new non-opioid medications for pain.
• Recommending that hydrocodone-containing combination products have additional restrictions on their use by rescheduling them from Schedule III to Schedule II.
END of extract - GO BIEL
