Replies to post #94078 on Anavex Life Sciences Corp (AVXL)

[F1ash]

"Thus, some proposals in Europe have called for earlier market release of drugs once they have completed Phase II clinical trials, with post-market surveillance thereafter to continually assess patient safety and drug efficacy"


"Drugs and Devices
Comparison of European and U.S. Approval Processes"


http://www.sciencedirect.com/science/article/pii/S2452302X16300638

[attilathehunt]

I have always thought A2-73 would get approved first in Australia because the trial has started there. Coupled that with the fact the government is sponsoring the trials, one would think the red tape on approval would be less restrictive in light of the safety and efficacy record to date. In fact, I believed approval would have happen by end of last year. It didn't. As much anecdotal evidence that has been presented, I can't comprehend why Australia hasn't pulled the trigger by now. It's safe and there are signs of efficacy. Piano player, painter and golfer. We know of 3 out of 32. That's 10%. Why not grant conditional approval, while gathering data on future patients?

What is the risk? What is the worse that could happen? Premature death? Death is inevitable and may be a welcome outcome for those seriously inflicted with AD and their families.

Being of sound mind and body today and knowing you will get AD and dementia what would you agree to do? I think many of us would opt to be treated and if we were to die (worse case situation) we would most likely suffer less and more importantly we would prevent all the pain, suffering and financial burden on our families. Why, why, why we can not achieve conditional approval based on results to date? What we know today, I believe any delay is cruel and unusual punishment.

IMO, the only reason for not having conditional approval is the data provided to us is not real. That is not the case (I hope) so the government (at least in Australia) needs to make a bold move and grant conditional approval while we still gather data.

It's not about the money. It's about dignity. Anyone having to go through this dreaded disease well knows the pain and suffering experienced by both victim and the families.

Though there appears to be a lot going on, it is time to be bold and make a decision. If what we have to date is real and it is safe and has signs of efficacy then where is the harm of granting compassionate release?

Sure we can have lawyers draft a release form or whatever. It's time to act.

Forgive me for my ranting. It's just that I had a moment of reflection of my grandmother. I was raised by my grandmother and she lived with me most of her life. And at the end she didn't know me. She thought I was her doctor and I couldn't help her.
I hope and pray that something works soon. I'm 64 and the thought of putting my family through this weighs heavily on my heart.