I understand where you are coming from. It has been a long and arduous journey. Broken promises and all. In addition, watching the SP go from $5 to $1 was painful. And frankly, if we knew what the last two years was going be like, we could have easily sold out much earlier and buy it again now...
But, here we are still SHs - long suffering MSB'ers
Parking my emotions aside for a moment and trying to look at this objectively...
How would I rate this coming Ryoncil BLA resubmission vs the original BLA?
Efficacy - ODAC 9-1 vote is already done - so there's no more to be discussed
CRL items - Assays are done with new data provided in the FDA IND file. This could be a risky item as the FDA has to tick this off. But, after taking 2 years and spending good money on this, I'm still a SH - I just have to back MSB on this.
Mock manufacturing inspection - this was able to be done this time around in readiness for the FDA inspection
Request for RCT - let the survival data from the Long-Term Survival for Acute GvHD Treatment with Remestemcel do the talking. Is that by chance is it? What's the point of these RCT? Survival got to be gold standard - and this is after 4 years! 4 years on high risks GVHD patients
Nothing is guaranteed, especially with the FDA, but I think we have the best chance that we are ever going to get here. If this Ryoncil BLA resubmission fails, then Sayonara to MSB - but, I choose to be optimistic and look forward to an FDA approval. It all starts with the resubmission though
GL MSB'ers
MSB Price at posting:
98.5¢ Sentiment: Buy Disclosure: Held
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