Replies to post #164181 on Anavex Life Sciences Corp (AVXL)

[tredenwater2]

Thanks for the post Kevlie. I certainly cant fault Dr. Missling for starting trials overseas ahead of the FDA's reorganization pains. Can you imagine having a trial in motion as these rules and regs change at every corner leaving you wondering about the end? At least when they finally do start we will have some confidence and focus on an ultimate goal. I really do believe that we are in/applied for a seamless, basket type trial especially considering the amount of trials we are starting. That coupled with what we have been pre clinically cleared to start tells me its going to be simply an amazing 2018-2019 time period, absolutely AMAZING!

Like the rain I can feel it.

Tred

[jtsmgoblue]

Good read.

Now let’s see them put these words into action.

[nidan7500]

Thanks Kevli33: Dr.G. says ...I have broken the code below.

We’re working closely with our public and private sector partners to better meet shared public health goals and address cross-cutting scientific and technical challenges, while making regulatory decisions more transparent and predictable for all stakeholders. My recent written testimony on how the FDA is implementing the 21st Century Cures Act contains an overarching picture of the agency’s many activities related to our new policies aimed at advancing innovative products.
I’d like to use this opportunity to reflect on how the FDA is creating a new operating system for innovation by modernizing clinical trials, streamlining the FDA’s organization and processes to advance regulatory science, and expanding the FDA’s capacity to analyze complex real-world data streams to detect early safety and efficacy signals. And to describe the new policies we plan to announce to advance these goals. These mutually reinforcing efforts will help the FDA meet its mission of promoting and protecting public health, and they will help unlock the full public health potential of America’s public and private investments in medical research.
Modernizing Clinical Trials for Drugs and Devices
Prospectively randomized, placebo controlled clinical trials are often the most powerful tool that we have for answering fundamental questions about the safety and efficacy of new medical products. But greater efficiency is needed, as clinical trials are becoming more costly and complex to administer. Moreover, many of the new products that we’re being asked to evaluate aren’t easily evaluated using these traditional approaches. At the same time, new technologies and sources of data and analysis make better approaches possible.

https://blogs.fda.gov/fdavoice/index.php/2018/08/fdas-comprehensive-effort-to-advance-new-innovations-initiatives-to-modernize-for-innovation/

Translation: If you are in a hurry to get things done as they should be then you need to go somewhere else while we get our shat in one pile...IMO. This help explain why Dr.M. was compelled to use other more tuned in countries (Aus-Spain-Other). May also splain why BP packed their AD bags and went on vac.