Today's meeting among the crisis management team will completely ignore what's happening in the stock market. People on this Board are doing exactly the opposite. The FDA and the scientists involved have put any financial considerations for weither Company way on the back burner. All the journalists, including Laurence Altman, M.D. from the New York Times have been mixing the SEC investigation as well as the plummeting share prices in the mix of their story. Practically all the headlines project a "new story" and condemn the drug forever. At today's meeting, I expect Igor, Jim, Kelley and the FDA higherups to keep a level head and get to the root of the problem. It's a scientific problem as well as a clinical problem. They will see a mix of basic science, immunology and clinical neurology and within a few months they'll understand the root of the problem. At this point everyone is in too deep to manipulate the outcome. It's now a highly public story. Don't be swayed by the headlines.
Agree, but you don't project far enough. ELN & BIIB's (simply ELN) researchers have already postulated the presumptive culprit and mechanism of action. The issue here is management policy: 1) if reasoning is true, then what to do about clinical practice, 2) does ELN have any early detection methods to grade/stage PML development, 3) does ELN treatment protocols for PML management, 4) if detected early, is the PML damage reversible, 5) is T worth the risk?
Those are big time policy decision which ELN better have some answers and suggestions to convince FDA they are actively managing this situation. Otherwise, FDA will manage it for them.