Replies to post #134159 on Anavex Life Sciences Corp (AVXL)

[anders2211]

I really dont think you are negative on Anavex and I hear you when you say "too many delays and disappointments along this bumpy road and I expect the rod to remain bumpy. " Thats got Anavex written all over it and btw many other biotechs I might add.

But... I still dont understand and didnt read from your post as in why if Rett is not given the green light on or before Jan 31, then the rest of the year (thats 11 more months) is flushed down the tubes too... is there some FDA regulation that after 60 days of not hearing anything from the FDA ...?
I dont know, I was just wondering why after that date in your view 2018 is a gonner too..

[Talon38]

Attila, No one could have anticipated the progress of the 21stCCA and precision medicine at the beginning of this year. Certainly, with the appointment of Scott Gottlieb as FDA Commissioner and his endorsement of Janet Woodcock's precision/adaptive trial initiative have moved things forward. However, as some people have noted that in government bureaucracy this is the revolutionary over running the evolutionary path of progress. So, there are just more than a few bio/pharma's in limbo about trial status and starts.

Chris and Tayo are working to keep us at the head of the line but I think we can imagine that there is a lot of pushing and shoving!

As to the Rest Syndrome trial, Dr Steve Kaminsky is just starting up P3 for Nueren's drug. He should have however, worked closely with us on participants and trial location at this point. He and CDER drive the train on our trial start so let's not beat up CM on the exact date.

On Parkinson,s, take a look at the MJFF website under trials and research and you will find over 700 entries. Here again Anavex may have looked at just when they could logically get a trial moving sponsored by MJFF, then looked at Lund or some other entity in Europe and found the latter more expeditious. Remember, the 2-73 human safety P1 was conducted by ABX CRO in Germany. And then there was the agreement with Rosekamp Institute for the development pf "Annex Plus". So, Europe is not new ground for 2-73 research. Lund University has laid the successful preclinical ground work for 2-73 in PD consequently, they would not be an illogical choice to conduct a P1.

The same would apply for WSU for M/S given the lash up between WSU, Anavex and and Biogen.

Finally the announcement of the Alzheimer's Clinical Trials Consortium is great news for a precision medicine P3 for 2-73 backed by ACTC infrastructure and money. The SAB connection has already been noted.

All in all, things are looking up....with a pinch of patience added.