Replies to post #187469 on Anavex Life Sciences Corp (AVXL)

[XenaLives]

Apparently there is little difference between the two in the U.S.

Although we often focus on EA as providing access to patients who cannot enter clinical trials, EA can also be considered as a mechanism for those who have participated in a trial in order to allow them to continue receiving a drug that may have provided benefit. At the end of a trial, sponsors may continue to provide treatment to participating patients through an extension study to gather additional rigorous information that’s needed to support the subsequent marketing application. Alternatively, if the purpose is primarily to provide the drug to patients who continue to need it, an EA program may be used for either moderately sized populations (intermediate EA) or large size populations (treatment EA), often when most studies in support of approval have been completed. As another option, a sponsor could authorize a patient’s own physician to obtain a single patient EA investigational new drug (IND) application.

Once a trial is complete, EA is generally available when clinical trial results show that the drug is effective in the studied population. However, sometimes drugs that have not shown benefit across the overall study population may still be providing benefit for individual patients.

In such situations, EA may have a role in allowing patients to have continued access to the drug. We would generally support such efforts. Providing EA to patients who undertook the risks that are inherent to participating in any clinical trial is an acknowledgement of the contribution these patients have made to the overall drug development program. Of course, in situations where an experimental treatment is potentially associated with substantial risk -- and where the therapy has not been demonstrated to be effective in a trial -- continued access must be carefully considered by the physician and the patient, and weighed by the sponsor, especially if further development of the drug is being reconsidered.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634766.htm?utm_campaign=032919_PR_%20FDA%20Statement%20on%20Expanded%20Access%20%E2%80%93Looking%20Forward&utm_medium=email&utm_source=Eloqua

[Fire Misleading]

Expanded use not going to happen here anytime soon. Not enough dosed in US for this and outcome might be placebo effect. All dreams.