Replies to post #137191 on Anavex Life Sciences Corp (AVXL)

[kld2]

FI, you make perfect sense. Logical, sensible conclusions about Ph2/3 AD trial.

[Mikesc]

Phase 2: Limited, controlled clinical studies
Study Objectives during the different
IND Phases

– Closely monitored, usually several hundred subjects
– To obtain preliminary data on effectiveness of the drug
– To determine common short-term side effects and risks

• Phase 3: Expanded, controlled and uncontrolled trials

– Usually several hundred to several thousand subjects
– To gather additional effectiveness and safety information
– To provide an adequate basis for extrapolating results to general
population and in supporting that information in the labeling

The old way... the new way should be more adaptive.

[Gernee20]

Flash - In adaptive trials, patients can be added to the trial. If they start with 200 for the ph2 portion of the trial, it is very doable- in an adaptable trial design- to enroll more patients for the phase 3portion of the trial after the trial has commenced and patients are taking the drug. One of the great aspects of an adaptive trial

[Amatuer17]

“My guess, (and it is a guess) is that reducing the patient estimates from 300 to 200 was a hint that the next trial will be a Phase 2b properly designed trial to test for efficacy rather than a Phase 2/3. “

Completely agree - with so many AD drugs failing FDA will not take risk of approving anything on limited data/results. They will definitely ask at least one P3 - so co as well may do a very good P2b

In any case we are looking at 2-3-4 year journey

[Investor2014]

If Anavex decided to restart with a P1 and do it all properly this time, they could also make a new deal with LPC and maintain Missling's life and hair style on investor's expense for another 6 or 7 years.

[XenaLives]

We are talking about a P2a here, not "most trials" - many P2a's are "unblinded and uncontrolled". The purpose of the P2a was to gather information about dosage and response levels. That is what happened.

Your entire post is one big red herring.

Why are most trials blinded and placebo controlled? Is it a good idea to put so many funding eggs into a Phase 2/3 basket based on results from a trial that was susceptible to significant bias because it was unblinded and uncontrolled? How many different doses will the next trial have with a sample size of only 200? What if the sample size, due to multiple doses, is too small for statistical significance?

[Hagrid]

Well though out and logical. Why the did Dr Donut commit to an unrealistic timeline? Look at all the angst this guy as created.