Anavex Life Sciences Corp (AVXL)

[nidan7500]

Dr. M. will need an army.

Sponsors must give the Agency adequate information to thoroughly critique the SPA and decide if it addresses the key scientific concerns. Therefore, any potentially problematic features of the study protocol should be addressed with sufficient information for the FDA to come to a consensus.

Despite the provided justification, the FDA does not always agree that the submitted protocol will satisfy all questions. Subsequently, a nonagreement letter can be issued. When a nonagreement letter is reached, the Sponsor has three general options. They can initiate the clinical trial without an agreed upon SPA, send a written response to the FDA regarding the nonagreement letter, or request a meeting to discuss the nonagreement letter. To ensure the most effective utilization of resources, reaching an agreed upon SPA is recommended before initiating the clinical trial. Depending on how many outstanding protocol issues are presented, a meeting or written response may be preferred.

The significance of the RETT trials continues to grow every day. No wonder they kept going w/the amyloid plaque trials even though a child could see they went no where. Powerful AI and strong intervention skills will be needed here.