Replies to post #465581 on Anavex Life Sciences Corp (AVXL)

[Hosai]

The aknowlegement of eligibily pr was in late Dec. The Nov 20th surely was the letter of intent as the content was basically saying we have met with EMA and can confirm we are planning to submit an MMA etc, if that's not a letter of intent I'm not sure what is?

[WilliamMunny]

All we really know is that Anavex filed to enter the rapporteur process on or before February 11th (as I recall the monthly openings). It was after the only January opening, since Missling said on March 4th that he was awaiting appointment of rapporteurs, which was scheduled to come later in March if that filing was in February. The LOI was either filed before the request for rapporteurs or at the same time. The projected MAA filing date at that time could have been no later than 7 months away, or September 12th (and I think, as someone here correctly mentioned, the EMA strongly prefers the rapporteur filing not to be less than 6 months from the projected MAA filing, so no earlier than August 12th for the MAA). I asked Missling at the ASM whether there was any issue with changing the projected date (knowing that he had a theoretical window to do so at that time). He said that such requests were made frequently by prospective filers. So, it appears he made such a request and pushed it out another month or two (and possibly three, but I personally suspect it would come in November at the latest.)