Nidan:
Thank you.
I am not saying that it is a sure thing. I am saying that the odds of some sort of FDA approval are greater here than in most clinical trials because of the indications for CNS diseases that have no effective treatment.
However, I suppose I am saying that Anavex is not on the verge of destruction. I see no evidence of that. There may be a lack of positive feed back due to the delay in a response from the FDA to proceed with the trials that management says will eventually take place. Missling said at the annual meeting yesterday that Anavex has a good relationship with the FDA. No positive response has occurred, but no negative response has occurred. From my personal experience, I am saying that I do not find the FDA delay by itself to be negative or positive. I find it to be normal.
I know of no reason to believe that the planned clinical trials will occur. If the trials occur in the second half of 2018 as announced yesterday, we should know shortly thereafter. The Rett trial, for example, is about 8 weeks.
At yesterday's annual meeting, some statements made that do indicate postive feedback. Some are as follows: Organizations like Angelman, Fragile X, etc. have acknowledged that they are exicited about the drug's positive signal for thier untreatable diseases, there is renewed confidence with the Illuminia data, more funding from third parties is expected, and the move to Europe of the Parkinson's trial that will be less expensive and has other advantages.
I am sure that you have good reasons for your concern, and I would like to know more about the specifics. It is obvious that this drug is new approach to finding an effective treatment for CNS diseases, and I am sure that major pharmacuetical companies and many others are skeptical; however, if Anavex can obtain an approval for any indication anywhere, in the U.S. or Europe, the skepticism may be overcome. After all, nothing else works for many of the CNS diseases for which this drug may be indicated.
