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plexrec

07/25/23 7:17 AM

#424258 RE: Schmiggins #424254

" or these job listings are just part of the con!"--will answer your last question 6 months from now--jury still out !!!!!!!!

sokol

07/25/23 8:55 AM

#424269 RE: Schmiggins #424254

The number of job openings is unusual. It could be that Anavex is gearing up for a global phase 4 trial, which requires the collection of data and reporting to regulators. This, of course, is not definitive proof, but the openings like programming, global pharmacoviligence, etc., is consistent with plans for a phase 4 clinical trial.

Phase 4 trials look for side effects that were not seen in earlier trials and may also study how well a new treatment works over a long period of time.

Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.

Postmarketing surveillance (PMS), also known as post-market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.

Post market surveillance is required by regulators such as the FDA.

https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments#:~:text=The%20phrase%20postmarketing%20requirements%20and,%2C%20efficacy%2C%20or%20optimal%20use.





Boopka

07/25/23 9:46 AM

#424274 RE: Schmiggins #424254

Consistent with Anavex's declared modus operandi which is to be primarily an R&D company and to outsource/partner outside of those parameters. The difference here is the magnitude and timing. A company has to keep ahead of the curve and it takes time (and resources) to hire, train, and properly execute. In these waters there is no room for error. Imo Missling is definitely showing a "tell" at the poker table and indicating that he is moving full speed ahead with a lot of confidence.

tschussmann1

07/25/23 10:50 AM

#424279 RE: Schmiggins #424254

I think the open positions posted are in total 11, not 20. Some that show something like "Associate Director / Director / Senior Director" are likely one position for which they adjust the title and salary based on qualifications and negotiating skills of the incoming individual. Still, this is the sign of a company that has confidence on what they are doing...these are mostly high salary positions.