In the past, I have made numerous FOIA requests for information. Generally, the FDA has 20 days to respond. However, my experience was the FDA never responded in 20 days, and it seemed to take forever for them to respond. I received letters within 20 days, but the letters merely said they received the request and are working on it. It always took forever to get any further response, and usually the response was pretty much non responsive.
I have followed drug approvals, but I have also dealt with the FDA regarding Citizen Petitions, Orange Book listings, and other matters. I find that the FDA is similar to other bureaucracies and slower than one might expect.
However, in all fairness to the FDA, they are often over burdened. It is likely the FDA is processing a heavy load with every clinical trial participant seeking to expedite clinical with less expense under the new procedures. The FDA Chief is new and they are dealing with new procedures. The government beauracy is not accustomed to moving fast and adjusting to anything that's new.
I think that approving the AD and Rett trials is more complicated and with more variables than many people on this board comprehend and, again, I am sure that the FDA is receiving many more filings with companies seeking newer, faster,and cheaper approvals.
Missling may have misjudged the timing, but I for one do not condemn him for that. I have no reason to doubt his honesty.
It certainly is in Missling's interest that the AVXL 2-73 clinical trials succeed. People complain about the stock he has received as an incentive, but his stock too will be worthless if no clinical trial succeeds.
Additionally, besides the FDA, I have dealt with a lot of state and federal agencies over the years. I cannot think of one agency that has been prompt, and generally I found that they cannot even be relied upon to respond within their professed timelines.
Therefore, because my experience is that stuff happens and delays are common, my expectations are much lower than many on this board.
Based on the large academic and scientific support for Anavex's drug potential therapy for CNS diseases, I believe the odds of an approval of AVXL 2-73 for the treatment of some CNS disease is relatively high. Once it is approved for the treatment of any CNS disease, it will be prescribed off label for other CNS diseases. Anavex's pursuit of the orphan drug process is smart. Anavex needs to take its time and put forth the best efforts for a successful Rett trial. Not starting the Rett trial on time is not important to me. Taking the time to make sure that it has the best chance of success is important to me and should be for everyone that has an interest in Anavex for whatever reason. We do not know the reasons for the delay, but I believe everyone involved in the Rett trial feels the same that delays are not significant -- success is!
