GUARANTEED 0% CHANCE OF FDA APPROVAL IN APRIL!
How can company insiders even spew out this type of garbage and sleep at night? The animal studies haven't even been completed yet, then after they FINALLY are completed they still have to analyze and break down the data and then prepare the data for submission and then officially submit an entire new DeNovo. FROM THAT POINT OF SUBMISSION it is another 120 days at least for a response normally, last year the DENIAL was nearly 180 days from submission. Just with this information alone it is guaranteed that there is ZERO PERCENT CHANCE of approval in April. NEXT TOPIC, APPROVAL??? As a CLASS II medical device? Has ANYONE HERE read the examples of a CLASS II medical device? CLASS II IS A CONDOM, that is used for sexual intercourse for anyone who is unaware. Y-90 RADIOGEL is INJECTABLE RADIATION, on what planet in what galaxy in what universe are condoms, which are inserted in vaginas regularly, comparable to a dissolving radioactive isotope injected into the body tissue? Certainly not on this planet Earth I can tell you that. Look at ALL the examples of Class II, not a chance in hell that this is approved as a Class II device. The first example of a Class III device is clearly and directly almost referring to Y-90 AND THIS IS WHY the FDA has ALREADY recommended human trials BECAUSE THEY KNOW that denial is once again coming and at that point they will request HUMAN TRIALS and then the song and dance starts all over again. Just like how AMIC KNEW that the fda wanted animal trials before the last submission but it wasn't yet "requested" so they submitted a phony application just like they are going to do again, but that submission won't be looked at any time anywhere near April. So besides spitting out false approval like it is fact when it is not coming anywhere in the near future (and I mean years and millions of dollars later), stop spitting out the false timelines that are so obviously impossible.
Company insiders should be flooded with guilt for how they steal from the honest public that they should want to hang themselves. I feel sorry for anyone who is still viewing this through MERLOT GOGGLES. The scheme is as obvious as a college athlete riding around in a flashy ride they can't afford but everyone turns their head to it.
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