Replies to post #390962 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

Yeah, but Anavex have not announced a SPA. SAVA did, but will they meet the conditions is another question.

Anavex will imo end up running at least one AD Precision Medicine P3 trial, which will very likely lead to approval.

[nidan7500]

JkS3, you may have this info or know where it should be.

AVXL are doing/completeing trials in a number of different countries simultaneously. Do you know who are the CRO's being used in each? Do you know if AVXL have precertitied/validated these CRO's for required crednetials proior to doing the trials. My guess is multiple CRO's in several countries, using complex technology and S/W-H/W systems starts to get to be a complexity -management issue very quickly. Simple things like REv controls and records management protocols/requirements can get hard to do while running at full speed.

So, keeping all the CRO's on the same program-time page, having evidence of each validated SW-HW system (see records/change control) are all fundamental to passing FDA-(in country) certifcation requirements.

Doing what must be done WW while trials are running AND while keeping FDA (other) certification requirements WW is a big job. I won't even mention time compression and criticality of each module or rev. controls.

Mind boggles w/trying to know where to start and how to know adequate CRO-Regulatory bodies controls are in place. Never mind doing all this against a time compressed schedule.

Any ideas if all that was done by respective in country CRO's in a AVXL program coordinated manner or if AVXL staff did such from a central control point?

TIA.