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Re: petemantx post# 321270

Friday, 08/28/2020 3:09:48 PM

Friday, August 28, 2020 3:09:48 PM

Post# of 403248
Here is the info...
As part of drug development, the FDA allows for potential Expanded Access / Compassionate Use of an Investigational New Drug before any regulatory approval might be achieved. This opportunity applies only to patients with serious or life-threatening conditions who are unable to participate in a clinical trial and have exhausted alternative treatment avenues.

For FDA regulations on Expanded Access / Compassionate Use, please visit the FDA website.

Patients and physicians should refer to the following information before contacting us about potential Expanded Access / Compassionate Use opportunities.
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