Thursday, May 24, 2018 1:12:17 PM
Well, I can see how there are other considerations that might make companies reluctant to provide treatment under RTT or Expanded Access.
If you provide under Expanded Access and the patient subsequently died due to SAE, then it could lead to the FDA putting your trial on hold.
Under RTT, the FDA is not supposed to be able to do this.
But, a company may have to disclose it to shareholders, and take a big hit to PPS as a result.
So I can see more of the downside for any drug company, under either scheme!
But I still think this could be a risk or a big opportunity for NWBO.
But they probably need a venture capital backer, who also sees the potential benefit to come along.
In NWBO's parlous financial position, then the drain on resources and the risk will loom large in LP's mind.
This link (from a Goldwater perspective) lays out the issues quite well, though it is from before the Bill was passed:-
http://righttotry.org/dead-on-arrival/
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