I did a comparision of the two trials in a different thread...

I did a comparision of the two trials in a different thread which ill copy below:

Lets do a comparison of Ruxolitnib vs Remestemcel-L trials:
Trial:

• Single arm open label 49 patients
• Single arm open label 54 patients (Study 001)

Day 28 ORR:

• 40.7%-44.4% on grade 3-4 (grade c-d)
• 61%-67% on grade 3-4 (grade c-d)

Day 180 Survival:

• 51% (n=25)
• 69% (n=37)

Safety:

• Multiple safety concerns/side effects including infections, sepsis, uti's, thrombosis and animia (adverse events lead to 31% of patients discontinuing treatment)
• No safety concerns identified with a safety profile similar to placebo (adverse events lead to 15% of patients discontinuing treatment)

FDA Decision

• Approved
• ODAC voted 9-1 in favour of efficacy however FDA issued a CRL recommending a further trial to establish efficacy and to provide more scientific rationale to demonstrate potency relationships

Ruxolitnib has had a previous trial for the treatment of myelofibrosis. The trial results clearly show that from the available data, Remestemcel-L is a superior treatment with a much better safety profile.

Could msb argue that if the COVID-19 trial is successful this would provide sufficient evidence of relevant efficacy and safety similar to Ruxolitnib extension from myelofibrosis to GvHD based on the 1 single arm trial above?