Here is a post from the MSB thread (again). This one is about the regulatory environment and associated risk.
https://hotcopper.com.au/threads/cell-therapy-news-articles.3765963/page-8907?post_id=52381601
Given PAR has had a Type C meeting and have addressed the FDA’s concerns in the trial design I think that it isn’t a high risk but one that should definitely be monitored.
another thing i was considering is that I hope our submission for approval isn’t going to be impacted (delayed) by a change in Government.
research reports and media, page-1460
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