Anavex Life Sciences Corp (AVXL)

[sokol]

I do Tom Demark counts and follow some other related services. There are no perfect indicators, but the services I follow are more objective and are more often than not good indicators of up and down moves. These are close to coinciding with the event dates you mention. I am anticipating buy signals this week (Monday - Tuesday through Friday) and possibly into the first of next week (the week of December 11). The counts I do follow some complex rules, and not all trading dates meet the rules as valid days to count. However, this is looking like it either has to be crunch time for a move up if there is going to be one between now and the end of this year. Of course, any move can always breakdown, which is why some traders use stops (mental or otherwise). Basically, I am not a short term trader. I have and am very long term this stock, but I do some shorter trades taking advantage of shorter moves up or down that has helped me to build up my overall “core” position as some on this board day. Hopefully, I will be very right in the long term. I have a high degree of confidence in the science, and I think that what the company is going increases the odds that it may obtain FDA approval for a NEUROLOGICAL INDICATION (note I do not use any specific indication) for AVXL 2-73 along the lines I reasoned in my post yesterday, which is as follows:

The probability that AVXL 2–73 will be approved for treatment of a NEUROLOGICAL DISORDER. That is what I am interested calculating in an OBJECTIVE way.

"Drugs for rare diseases have higher than average approval rates for every stage of the FDA approval process......

For example, 76% of rare disease drugs moved on from phase I trials, compared to 63% of drugs as a whole and 58% of drugs for rare chronic diseases. Similarly, 50% of rare disease drugs moved from phase II to phase III, compared to 30% of drugs overall and 27% of drugs for common chronic conditions. Overall, 25.3% of rare disease drugs successfully completed the full process of review from phase I to approval, compared to 9.6% of drugs overall and 8.7% of drugs for chronic conditions.

The reason for these different rates of approval rates is unclear. It is possible that is simply easier to design effective drugs for rare diseases, many of which are genetic diseases with a single identifiable cause and a clear drug target......

It is also possible that the approval process itself gives greater allowances for drugs designed to treat rare diseases, even if this is not explicit. Under the FDA’s Safety and Innovation Act (FDASIA), the FDA is required to incorporate patient input into their review and decision-making process. The FDA may in practice be more likely to approve a drug with borderline conclusive effectiveness for a rare disease population, as these drug trials often face challenges in getting large numbers of study participants....."

http://www.raredr.com/news/orphan-approval

Yesterday, I did not have time to listen to all that Dr. Gottlieb and Dr. Collins had to say in their testimony. However, I believe I heard them say that emphasis is on faster approval of drugs for rare diseases, Parkinson's, Huntington's, and Alzheimer’s diseases. Further, clinical trial recruitment is made more efficient. The FDA is advancing protocols to enable more coordinated ways the use the same trial structure to evaluate treatments in more than one subtype of a disease or type of patient. The latter approach is relevant when it comes to targeted drugs. These drugs may intervene on markets that are relevant across many disease subtypes. The FDA may want to evaluate these different targets simultaneously. This could give the FDA a better way to understand the comparative benefits of a drug across different settings. The real life patient experience is now taken into consideration when approving a drug, and the Cures Act is helpful in expediting drug approval, etc.

Therefore, I do not think you can rely on historical percentages in estimating approval of a drug and/or the time it may take to approve a drug such as the historical 5% approval rate for Alzheimer clinical trials. Even then, we have 3 clinical trials being designed, one of which has obtained Orphan Status, which I think is important as I discuss below.

I believe Dr. Gottlieb also said that once a drug is approved for one indication, the FDA considers the approval factors for that drug for additional indications that may benefit from the drug.

Neurological disorders were discussed in general, and Dr. Collins mentioned incentives for the development of the treatment of neurological disorders that show some promise.

Adaptive trials are now encouraged by the FDA, which save money on clinical trials (this is me talking here), and the additional incentives that may come along the way help companies continue with trials for rare diseases and for neurological diseases in general. Incentives may be provided by the government, and we also know that incentives are provided by foundations. Therefore, you cannot use historical information to accurately estimate the costs of these clinical trials. All of what I have said makes it more likely today that companies will be able to fund these types of clinical trials like Anavex is doing.

Importantly, if AVXL 2-73 is for a rare disease, you can bet that AVZL 2-73 will be prescribed off label by physicians for neurological diseases, such as Alzheimer’s that do not currently have effective treatment.

I am not knowledgeable about statics, but perhaps someone on this board is. I would like to have an estimate of the odds for approval of AVXL 2-73 for at least one neurological indication as well as an estimate of the probability of how long that approval (or denial of approval) may take. I like to try to look at objective factors and exclude subjective factors, including investor bias. Is there some sort of objective model that may be developed to consider factors like I have discussed above to come up with the probabilities for approval of AVXL for any neurological indication and to estimate the probability of how long the Orphan Drug approval process for AVXL 2-73 may take. Once this is determined (but only then) estimates may later be considered for potential revenues, and probability of profit as well as possibly estimates of share price.

I will end by saying, I understand that my investment is a gamble, but I do not know how the odds compare to a flip of the coin (but no investor ever made a great deal of money without taking risks).