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Yes @davos97I think (hope) a successful COVID-19 RCT will be a...

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Larrynic

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05/10/20

15:24

Post #: 47858980
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Originally posted by davos97: ↑

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?

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Yes @davos97
I think (hope) a successful COVID-19 RCT will be a quick path to approval of Ryoncil for peadiatric GVHD.
MSB Price at posting: $3.51 Sentiment: Buy Disclosure: Held
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