I'm sure everyone appreciates your tenacity in communicating with Paul Fuj
From your post - Paul's response, I've highlighted in X's below some points I find very interesting and my comments......
Just received this from Paul:
Greenwood’s market is the US. They work with Ceuta International outside of the US. Ceuta is exceptionally good but outside of our price range. Gro-International works with Ceuta and Greenwood, XXXbut has given us a good fee, mostly contingent on performance. XXX (It seems to me that the deal with Gro-International may allow them to profit from S/p upside, thus they were 'allowed in' to pick up over 36 million shares at bargain prices on Feb 14 and 15.)
We still plan to use Greenwood in the US. XXX Most Canadian product launches occur after the products are established in the US.XXX (
The naiveté and stubbornness of Mr. Whelan caused him to go to Canada in a huff to show up the FDA for its delay of BIEL's approval here - bad boy - he did not realize, probably through inexperience, as everyone in the pharma industry knows, that Canada does indeed follow the USA, except in matters of regulatory approval. I'm advised Health Canada is competent and less tied up in bureaucracy, thus their faster assessments and approvals or rejections, but the retailers still ask, 'has the FDA approved this?"
The clearance issues on Allay and ActiPatch are exactly the same. The clearance denials are incomprehensible, XXXwe are still ongoing discussions at the FDA’s Office of Science Integrity.XXX
(Huge - the discussions continue, obviously behind closed doors, exactly where they should be taking place)
XXXIt is very difficult to negotiate with the FDA in a public arena.XXX
(This seems magical to me - The FDA should never be put in such a position as negotiating or having scientific explaining take place in public! It tells me that there may be discussions or negotiating taking place privately, which is appropriate. As I posted a year or more ago - this may still be about saving face. An applicant never gets approval by embarrassing an approving body!)
Appeals on 510k’s 091817 and 092931, ActiPatch and Allay are predicted on classification IMJ not the “non-thermal” ILX code. We are not petitioning for a non-thermal classification, it is this misclassification we are appealing. It is our assertion that over 30 years of research has produced no convincing evidence of any non-thermal effects with RF therapy.
XXXIt is now the scientific community’s widely held consensus and the Agency’s that there are no physiological effects from shortwave RF therapy that are not thermally related; that is, there are no non-thermal effects of RF exposure.XXX
(Fuj - if this is absolutely accurate, we may be in business and you should get to Paul and tell him to button up - I can only assume he was trying to be helpful to you, but no one should be stating another's position at this point, things may be too delicate)
I also like Kingsransome's post #28172 about 5 cents without a r/s. My take is that if BIEL went north of 12 cents a few years ago on hype, where will it go on FDA approval?
Cheers
