Replies to post #83853 on Anavex Life Sciences Corp (AVXL)

[bas2020]

Thanks for the summary; I concur with your assessment. How is the exclusivity applied? Can a competitor begin developing a copycat drug in that timeframe? Can they begin their own trials (just not P3)?

If they can't begin trials during the exclusivity period, then effectively it's a 7 - 9 year exclusivity period, due to the several trial phases.

[gburgin]

sokol, great post. You said "I have posted something like this before, but here it is. Anavex will have some form of exclusivity for AVXL 2-73 for AD alone not to mention the exclusivity it may have for all of the other uses. It certainly has 5 years FDA exclusivity in the U.S."

That is exactly my understanding as well. What do you think about that patent that was granted in 2015. I've been bashed over the head for saying it does not cover 2-73 as a mono therapy for AD. I'm talking about the patent with 16 claims that all say melanoma. What is your take on that patent?

[PeterKarol]

Sokol, thank you! You have assuage my fears. I have looked into the data from AAIC 2016 and CTAD 2016 data and replotted it to my liking. I noticed that in AAIC data there was group of patient called A2-73 Alone who had a surge in MMSE scores. In CTAD 2016 data a group of 6 patients called MMSE Strong exhibited the same performance and extended it few additional data points in time as the prevoious data was limited to 31 weeks. It semed that Anavex did not name the second grpoup "A2-73 Alone". Did they want to avoid revealing the efficacy of A2-73 alone versus the combination as I thought that the only way forward in case of expired patent was to pair it with another drug and patent the new drug combination. From the analysis of data I realized that A2-73+DPZ failed. What I saw in the data pointed to strong efficacy for A2-73 Alone with surge then stabilazation then nacent surge (MMSE scores) which I hope will pan out into moving scores into vicinity of 28-30 MMSE that is possibility of cure. You can see my graphs on twtiter @piotrpietrzkiew. sorry for being sloppy with language.
There is interview from Australia and ppl claim that 300 patients will be dosed in Melbourne, would it be the only site? If this is true then this relatively small number of patients confirms my hunch that there is high efficacy in P2a. DPZ had 800 patients, some drugs in P3 have 3000 or so. In general the highier number of subjects in trial the less efficacy encountered in P2 as you try to separate weaker signal from statistical noise in P3.