Replies to post #135943 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

Nicely done, thx.

[BIOChecker4]

Pay attention the carefully crafted language: "...the Company anticipates dosing the first patient in due course following FDA approval of the IND."

In other words, this is open ended and could go on for some time. We don't know what the FDA's concerns are and we don't know what AVXL must to do to satisfy FDA or how long it could take.

[BioMojo]

Tred, I am in total agreement with you on the Rett trial and stated the same sediment on this board a month ago. There is no requirement for AVXL or any company to pr the start of a trial. I believe they only enrolled 32 patients and are well into the trial. We will soon know if we are right! GLTY!

[imho]

"The Company filed an IND for ANAVEX®2-73 in Rett syndrome, for which the Company received orphan drug designation by the FDA, and is expecting feedback from the FDA to finalize the clinical trial protocol for this study. As start-up activities with clinical trial sites have been underway, the Company anticipates dosing the first patient in due course following FDA approval of the IND."

IMO with the company NOT PR'ing the "filing" of the IND (as others here indicated was needed and therefore positively has not been done) I believe next PR will reveal that the Rett trial as been started, perhaps in the 10q.

Not necessarily. The quote above comes from the Dec 11, 2017 press release of the financial report. It could also serve as the required PR, in which case the IND was filed on the eve of the above PR. If one believes the IND is "material" and thus requires a PR, then this is the only explanation.

IMHO