You'd be right to have more faith in it if she had contributed to that part, but that's all me.
I've held off telling one of the most interesting things she said. I told her the optimist crowd on the board put a lot of stock (no pun intended) in Missling saying endpoints were met. We had already discussed the TLR, and she'd found it very weird that a means test comparison was omitted and that the Odds Ratios info did not include the over-threshold n. (When I say those things, yes, that is me channeling her.) She also said, without any prompting from me and without my ever having mentioned a PM trial, that she saw a PM trial coming next. (This was all a while back.)
So I asked her: "Have you ever known a CEO to say endpoints were met when they actually weren't?" She answered, "No, never. They can end up in jail for doing that. What they'll say is something like, 'We're very pleased with the trial and we're optimistic the FDA will approve the drug.'" After a couple seconds she added, "But I've also never known a CEO to say the endpoints were met and leave such gaping holes in the TLR!" (All paraphrased, but you get the idea.)
On a subsequent get-together, she expressed amazement the holes hadn't been filled in yet. She said there's nothing to determining the missing pieces (means comparisons, odds ratios, etc.), it can be ready almost immediately after you get the results from the CRO; you should have the framework for the statistical analysis for your primary endpoints ready by then and you just plug in the data. But now we get to another insight of hers that I channelled:
She said the small companies she worked for were always looking for funding, which motivated them to put out quality TLRs. Anavex didn't have that pressure as it has a good money runway, so maybe that's why they haven't done it. I added that (a) small companies that have VC funding probably have to tell the VC honchos how things are going and securities laws prevent them from doing it non-publicly, and (b) BPs probably have to be more responsive to their shareholders and directors, and so they wouldn't put out a TLR that omitted the expected statistical support. (She's worked for small biotech companies and BPs and CROs.) From this conversation came my theory that maybe Missling & Company hasn't issued a proper update to the TLR "because they don't have to" (in combination with fear of setting themselves up for pot shots from the world's AFs and not really accomplishing anything useful -- except for nervous shareholders, like me; that from the long view, it makes sense to wait and put out a comprehensive paper that may actually persuade skeptics).
