Yes, read through that. Mostly a bunch of beuracratic "junk" that suggests more study is required. In the "real world" it comes down to can/will the FDA look unfavorably upon RCPI for making the product available under a "compassionate use" justification?...I would think that they indeed WOULD look unfavorably upon this...and as long as FDA is necessary for approvals into the various stages of IND progress in USA, I suspect RCPI will elect not to even touch such a justification.
The baseball analogy would be Pete Rose...he may not have bet on baseball since his banishment, but hanging out in casinos (and admitting that he did bet on the Reds to win) since his banishment has hurt his case for reinstatement.
BTW, have not seen anyone claim that Anatabloc is "life saving" with alternatives being unavailable.
That said, I am plenty upset that I will run out of Abloc and will not have accesss to it. I credit it for my healthier heart stats and low cholesterol.
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