Replies to post #363116 on Anavex Life Sciences Corp (AVXL)

[jav0033]

Im with you BIO, he’s not CEO material. Maybe he can work in the back assisting European operations/expansion. His word has no weight or value, proof is the many many conferences he attends which generate zero interest from other investors or Big Pharmas.

[Steady_T]

What specific things might Missling not accomplish to "get A2-73 over the goal line"?

There are 3 trials underway. Trials are requirement for approval so that step is accomplished. Statistical analysis has been done on the previously completed trials successfully. The agencies had to approve of the submitted data to sign off on the subsequent trials. So the company has demonstrated the ability to complete trials and prepare the data, submit it to the relevant agencies and have it found to be acceptable.

Preparation of an NDA is not done by MIssling personally. Missling has hired former FDA staff with significant experience with NDAs. We have been told on the board that NDA and clinical reports are generally prepared by hired medical writers. There shouldn't be any issues with getting that done if that is the case. If they don't hire outside NDA preparation help, the company has shown the ability to prepare data and reports already.

So it doesn't seem that there are any issues getting an NDA prepared and submitted once the trials are completed.

After that it is up to the agencies to evaluate the NDA. So far the data we have seen appears to be sufficient to more than surpass the current SOC, so approval seems likely.

That gets a drug approved. Next up is building up the manufacturing capability. The company has already shown the ability to acquire many thousands of doses in at least two different forms and multiple different strengths. So that seems not to be an issue.

Then there is distribution and sales. Missling has already said that for the larger indications the company will partner to solve that issue. He also has said that for the rare diseases the company will go it alone. Missling has already built strong relationships with the rare disease community which has created significant awareness of 2-73. Marketing to the rare disease community won't be an issue. Distribution will take place with any one or more of the existing major drug distributors. So that won't be an issue.

So what specific things do you have doubts about Missling's ability to accomplish that would prevent "getting A2-73 over the goal line"?

Trial results are all that matter. The rest is very doable.

[Amatuer17]

At this point, M has not developed a team that is needed to get a NDA filed and get product approved.

I will prefer the co gets sold at good price once the product shows good result in AD trial. We are at least 2-5 years away from 1 st approval