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Re: None

Wednesday, 06/20/2018 5:43:49 PM

Wednesday, June 20, 2018 5:43:49 PM

Post# of 21540
An informed opinion on the Right To Try Act:



"The #RightToTry Act was problematic from day one. No one should be surprised that many companies won’t participate (eg, $SRPT) and those that do are driven by the ability to recoup cost (which could be very expensive). These issues and more were raised prior to RTT becoming law"

I'll add further to this:

- What if someone using a Right-To-Try drug has a bad outcome (e.g. death)? There are no controls such as you would see in a trial, no follow-ups, no monitoring, no inclusion/exclusion criteria. But, if there is a death in a drug being used as part of the "Right-To-Try" Act, the FDA could require a clinical hold on trials until the death is understood.

From my perspective, the downside risk of Right-To-Try act outweighs the upside.

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