Replies to post #367591 on Anavex Life Sciences Corp (AVXL)

[XenaLives]

If earlier trials show a strong response, even the Alzheimer's trial does not have to be a large trial.

If there are multiple P3 trials showing a strong response they will reinforce each other.

Phase 3:

For diseases affecting many patients, Phase 3 studies typically involve 300 to 3,000 participants from patient populations for which the medicine is eventually intended to be used. Participants are assigned to receive either the medication being evaluated or a control group that receives either the current standard of care treatment or a placebo (a substance that has no therapeutic effect). Researchers design Phase 3 studies – among other things – to demonstrate whether or not a drug candidate offers a treatment benefit to a specific population provide more detailed safety data, and serve as the basis for product labeling.

When one or more Phase 3 trials are completed, the researchers examine the results and decide whether the drug has demonstrated effectiveness and an acceptable safety profile in treating a disease. If so, the company can submit a New Drug Application (NDA), which contains all of the data and information gathered at every stage of the process through the results of the Phase 3 clinical trial(s), as well as other information required by the applicable regulatory authority. The NDA is submitted to the FDA (or analogous applications may be submitted to other regulatory agencies outside the US) for consideration for marketing approval. Because Phase 3 trial results often provide the basis for approval, Phase 3 trials are sometimes also called pivotal trials. If the drug is approved, doctors can prescribe the medication for their patients.

https://www.concertpharma.com/understanding-clinical-trial-terminology-whats-a-phase-1-2-or-3-clinical-trial/

[JWC3]

Phase3 clinical trial results have been in the hands of CEO Dr M for about a month now, for the 509 patient 48 week AD trial! There is a requirement to report any negative results immediately. No negative results have been reported, therefore the AD TRIAL HAS NO NEGATIVE RESULTS TO REPORT!

[tredenwater2]

Phase 3 Trials Are the End-All, Be-All

Falconner, Dr. Misslings comment comes to mind here about how “when we run a Ph 3, it is to confirm only what we know from the Ph 2, not further exploratory.” (Paraphrased) In other words when we officially went from. Ph 2b into a Ph 3 I think what he was trying to communicate is…….#WE GOT THIS!

Cheers