of any CEO that submits to the FDA a comparison of an image of a hand to an image of a skull and gambles millions of dollars of shareholder money the FDA will accept the comparisons as valid to demonstrate Substantial equivalence.
Even as a layman I understand that equivalence can only be demonstrated by comparing identical (not just equivalent) subjects.
I question the truthfulness of a CEO that rants on Facebook that he cannot understand why the FDA would require financial disclosure from a radiologist whose opinion is included in a submission package that can impact a company's market cap by hundreds of millions of dollars. Financial disclousre has ALWAYS been a requirement.
Even as a layman I understand that you have to disclose what your financial interest in a company is when your opinion, up or down, DIRECTLY can impact the value of a company and the safety of the public.
vino, I agree, if Dean lied so blatantly, as has been professed, it should've been a slam dunk? Such is not the case, if it's not clearly evident to us lay people, it just ain't gonna fly in a court of law...as we have seen! And as an additional thought...if the case was news enough to be stickied, the dismissal decision should also be there as well!
Even receiving FDA approval will not erase the misrepresentations Mr. Janes made regarding the FDA letters. Even if my appeals fail, the road has now been paved by this judge's decision. He has made it clear exactly what is needed to survive a motion to dismiss. I assume that I will not be the only one to ever sue this man on this issue. We shall see what the 9th court of appeals has to say. One thing is for sure, there will be such a decision as I am moving forward with the appeal. The notice of appeal has already been filed and served.
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