Thursday, November 18, 2021 10:59:27 PM
I believe we will get and answer tomorrow, but I no longer have faith in my ability to read this case.
I believe that the case is a clear one, however, and one that I have not fully revealed which is why I do not believe LP passes SNO bye without some meaningful news. She is an attorney after all and should know when to seek legal advice from someone with the appropriate specialization.
Why? Because it is reasonable to believe that they needed a forum like a publication or SNO to break news that DCVAX is not fully safe or effective for the treatment of GBM, but at this point or more precisely by the time we reached the LBA deadline it is no longer reasonable. At that point they must correct an overstatement of efficacy claim to me at the earliest available opportunity.
I guess if everything is great you could continue to wait for some odd reason, but why would you? You cannot wait any longer for a misinformed claim of efficacy, however. You must correct that promptly and adequately, which is my well-informed opinion.
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