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Re: Thehubby post# 459504

Tuesday, 05/21/2024 3:35:49 PM

Tuesday, May 21, 2024 3:35:49 PM

Post# of 473567
Thanks, I had forgotten about that term, sounds right...

So I should prepare a presentation for my new neurologist and let her contact Anavex.



How Can Patients Access Compassionate Drug Use?
Patients who wish to be enrolled into an active compassionate use program must have a treating physician willing to prescribe the drug and complete the application process, on behalf of the patient. The physician must decide that the potential benefits of using the unauthorized drug outweigh the potential risks. The physician must also administer the drug and monitor the patient. When necessary, the physician will be expected to provide any safety and efficacy data to the drug company or applicable health agency. In the US, that would be the Food and Drug Administration (FDA).

In the case that the product being provided is an investigational drug, the term compassionate use program is often used interchangeably with Expanded Access Program (EAP). An EAP refers to the use of an investigational drug to treat a patient outside of the clinical trial setting. In the vast majority of EAP cases, the drug is provided at no cost, which is why an EAP is often referred to as a compassionate use program. More can be read about compassionate drug use through expanded access on the following websites:



https://www.wepclinical.com/what-is-a-compassionate-use-program

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