The article tries to highlight the positive aspects of the news, however no mention of RMAT designation, and what that would mean to the timeline of approval.
The timeline outlined is a much longer duration for approval then the timeline generally speaking under RMAT designation. I could cite examples of 6-12 months for previous approvals under RMAT designation by other biotech companies.
Secondly, it's designated for patients that have no alternative, so imo, why should it not be fast tracked for approval if the safety and efficacy are there? Sometimes things don't make sense.
Don't mean to sound negative, however i was disappointed with this news.
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