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Sunday, January 10, 2021 2:01:34 PM
Re: yaro1 post# 30471 0
Post # of 30885
Not necessarily, we already have FDA class ll approval, but changes to the product as I mentioned a few post back require recertification—“substantially equivalent” SE to be marketed, Quote, ”Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within “90 days” and is made based on the information submitted by the submitter.”
—Article: “We're going to see a lot more consumer tech devices get the FDA's blessing. Here's what you need to know. June 13, 2019 5:00 a.m. PT”
So we do know for fact: Ongoing El Camino trial means CBM is being “funded & tested”...! (My Investment experience means those words are “code” for 1), El Camino sees “”merit/potential efficacy in the CBM””
or it simply would not be allowed anywhere near their facilities ((Actually their very words when Trials started NOT Cyrcadia’s)) & 2)LLBO outstanding O/S has not been further diluted, due to the Cyrcadia restructuring several years ago ((and private funding I posted recently, JH)) with Cyrcadia incurring the additional funding for the on going trials...without having to issue any more LLBO shares @ sub penny valuation.
“Elementary, my dear Watson”
You know this stock is like a big big big Craps table, you buy the dice (bet on a number) & roll them, but they just keep rolling in perpetual motion, someday the dice will stop rolling & land on a number...? Every day the dice are slowing down...!!!
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