Replies to post #132245 on Anavex Life Sciences Corp (AVXL)

[XenaLives]

Rather odd - says "Release only upon delivery", and it was released a day before delivery.

[nidan7500]

Anyone know what these 11 RMA designations are/include?

One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies.

The Cures Act recognized these opportunities and highlighted the need to establish enhanced pathways for these promising therapies. Immediately after the law passed, CBER moved quickly to establish the Regenerative Medicine Advanced Therapy (RMAT) designation program, as authorized in section 3033. This program aims to facilitate an efficient development program, expedited review of innovative regenerative medicine therapies, and provide more timely access to potentially life-saving products. Products granted designation are eligible for increased early interactions with FDA, including all the benefits available to breakthrough therapies. As of October 31, FDA had granted 11 RMAT designations.

http://docs.house.gov/meetings/IF/IF14/20171130/106667/HHRG-115-IF14-Wstate-GottliebS-20171130.pdf

[kund]

Testimony going to be blah blah and more blah...don't see any substance in the released document.

[nidan7500]

"Regenerative Medicine

One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies.

The Cures Act recognized these opportunities and highlighted the need to establish enhanced pathways for these promising therapies. Immediately after the law passed, CBER moved quickly to establish the Regenerative Medicine Advanced Therapy (RMAT) designation program, as authorized in section 3033. This program aims to facilitate an efficient development program, expedited review of innovative regenerative medicine therapies, and provide more timely access to potentially life-saving products. Products granted designation are eligible for increased early interactions with FDA, including all the benefits available to breakthrough therapies. As of October 31, FDA had granted 11 RMAT designations. "


Sure looks like empowerment and new rules...

[powerwalker]

Disappointing that there is no mention of CNS in speech and Novel Clinical Trial Design set for public hearings in March 2018.

[123tom]

I read the first part ,and when it said....

"solidifying FDA's gold standard for safety and effectiveness" I had to stop and write this reaction..... We will know that progress has been made when the new 21st century drugs commercials on TV, no longer have the enormous disclaimer spoken at the end ,saying
"Side effects may include....stroke, vomiting,nausea,diarreah,dizziness,convulsions and death...stop taking this drug if you experience any of these symptoms." yes....FDA has done a great job with safety haven't they.
The FDA is a gate keeper for big money pharma to keep the cures out of the industry. This is a revolutionary need to change the system. it wont change any time fast. I suspect the government scientists already have the cures for the diseases, like cancer,etc....but they haven't brought them to the public, and Now, the public science (companies like Anavex and others) are catching up to the govt.science, and so the FDA has to deal with this issue now. They have suppressed various cures for as long as they can,and now they have to open the gate...just a little more....just a little, as little as possible, so the big pharma can still make all the billions of profit in the illness industry. But since the chemtrails are flooding the world with aluminum and other alzheimers causing chemicals, maybe they will open the gate a little more for companies like AVXL. who knows.

[investor300]

I wonder if the excerpt below means the trial announcements will be on hold until after this March 20th public meeting.

Novel Clinical Trial Designs
As technology improves, so does FDA’s ability to explore novel trial designs that better fit the
needs of researchers and patients. FDA is committed to supporting the use of novel trial designs,
modeling, and simulations in drug development and review, to do things like support evidence of
effectiveness, optimize dosing, and evaluate adverse event mechanisms.
Building on work that was already underway at the Agency, the Cures Act specifically calls on
FDA to assist sponsors in incorporating complex adaptive and other novel trial designs into
proposed clinical protocols and applications for new drugs and biological products to facilitate
more efficient product development. To do this, FDA is actively planning a public meeting for
March 20, 2018. The Agency plans to issue guidance on, among other things, how to use such
novel trial designs, how they can help to satisfy the substantial evidence standard, and what are
recommended analysis methodologies.