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old biohf guy

04/19/16 8:08 AM

#5055 RE: Jayyy #5054

Several comments here:

Can you explain the missing sentence from your previous post as pointed out by sweetlou?

The FDA denied marketing as a herbal over the counter supplement, but this is not a total denial of th product.

As for re-applying as a drug, this was adressed a while back. The answer is FDA approval requires lot of money which Roth does not have, so Roth decided to market in countries like Canada and Mexico where there is already approval. India should also be approved before the end of this years if all goes well as expected.

IR never said they were not interested in the US market. The US market is for the future.

The $15k for the promotion is mere pocket change compared to the millions it would cost for FDA approval.

As for misleading press releases, can you be specific and tell everyone exactly what was misleading?
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sweetlou

04/19/16 9:52 PM

#5069 RE: Jayyy #5054

"Pleas don't add your thoughts into a legal document from the FDA"

Let's be clear. I took your posted excerpt from the FDA letter and clearly identified any of my comments placing them in italics and saying so. That draws outrage in your comment. Interesting that it was apparently ok however to surreptitiously modify a Consumer Reports article to falsely implicate Sucanon and do so in your own words "to scare people away". I suggest looking up "double standard" in the dictionary.

"The denial is clear"
Very true. A denial to sell Sucanon as a supplement because it has undergone substantial clinical investigations as a drug.

"Certainly anyone should read and come to their own conclusions."

An excellent idea. That's what old BIOHF guy has said all along and has provided links to allow just that. I have promised and delivered on posting as fact only statements and information that is publicly verifiable. I find the FDA mentioned "substantial clinical investigations" of Sucanon. Their own words and it appears to be a complement rather than a criticism.