Replies to post #131457 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

Apologies for barging in with an attempted answer.

I think it may be simple:
1) with all the data understood (as well as can be), Anavex will determine inclusion/exclusion criteria so as to optimise the chances of a pass
2) The pass criteria, endpoints, will be agreed upfront with the FDA and noted in the trial protocol
3) Once the final trial readout is presented, the FDA will decided if they agree that the pre-specified endpoints are met.

If 3 is true, then pass!

[falconer66a]

It’s Still Simple. It’s Only: Is It Safe, Does It Work?

IMO his [Missling’s] cautious responses are to be expected at this point. How can he and FDA get on same track?

Many have questioned Dr. Missling’s carefully crafted, too infrequent, and putatively incomplete or inadequate statements about what the company is doing to conduct any of the promised Anavex 2-73 trials, which are required for FDA approval of the drug. Many are frustrated by the delay of these trials. Some believe all of this indicates utter inadequacies of both the company and the drug; and both are headed for failure.

Those with these perspectives, however derived, are welcome to them. But several facts remain in control.

First, drug approval regulations are in major revision, not yet fully determined or published (as far as I can tell). Contemporary science, including genomic analysis, advanced biochemical and microbial analyses, and advanced computer data analysis may all be involved, particularly as to participant selection. This makes construction of any trial presently tentative. What is going to be tested, how, and when has yet to be determined for each disease target. FDA hasn’t yet revealed exactly what they want to see.

So, just how could Anavex principals be laying out for the public exactly how and when their new trials will be conducted? Not possible yet.

Because of this, Missling must be diligent in not setting out anything that actually might not come to pass. That could be regarded by the tort lawyers as misleading investors. If it’s not said, it’s not evidence.

But, to the question at hand; how can Anavex and FDA get on the same track? Simple. When the details of the new trials regs appear, construct the three new trials in exact agreement with them. Privately, I’m sure, much of that plan is tentatively in place. But revelation of any of it, would raise legal problems if, in the end, some things were run differently in the trials. All the stuff that tort lawyers make their fees on, for disgruntled (or exploitive) investors. [There are legal operatives in some law offices dutifully copying virtually every word Missling speaks or writes. Juries will want to know, exactly what he was telling the investment community, and when. Millions of dollars may hang on those statements.]

No matter the form or requirements of the new FDA trails regs, only two things need to be determined. First, is the drug safe? Do its side effects out weigh and over bear on its benefits? (Many drugs have rather severe, even lethal side effects, but, all in all, the drugs provide desired benefits.)

Secondly, and even more importantly, does the drug provide adequate benefits, better than existing drugs or therapies?

There is not a requirement that the company, or its trials, reveal exact reaction cascades or other precise explanations of the drug’s mechanisms of action. Yes, the company’s biologists really want to know those, in as much detail as possible. With that knowledge, new drug tweakings for greater safety or efficacy can be worked on. But none of that is derived from FDA drug approval trials.

Even new drugs can be synthesized. But FDA pays no attention to any of that. Do the trials, properly-configured to the new regs, prove safety and efficacy? Simple as that. All of the contentions of Missling’s poor performance are irrelevant. I marvel at all of what we read here on the topic. Takes me back to dormitory arguments among a number of us biology undergraduates, debating the competencies and presentations of various professors. Irrelevant. Simply, could we in the end pass their exams?

(I did, thankfully.)