I am going to blaspheme.
The FDA did not approve Rynocil as MSB did not establish efficacy to the standards the FDA required. It was no FDA conspiracy.
And, it was not purely based upon AGVHD-001 being a single arm study.
The single arm study did not cut it as the FDA did not buy the null hypothesis and use of failed trials to support it.
MSB Trading 2020 - a new dawn, page-9178
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