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Re: Schmiggins post# 424254

Tuesday, 07/25/2023 8:55:35 AM

Tuesday, July 25, 2023 8:55:35 AM

Post# of 458068
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.





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