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Bluebird Bio is down 78% over the last 12 months....

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baddols89

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21/06/22

07:28

Post #: 62103911
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Originally posted by Bazsa: ↑

I am starting to think that FDA may have requested more data in the same way that they required more sub annalases for efficacy.

It's fairly clear that due to the lessons learned from the GVHD CRL that the final potency assay for Rex. is also being upgraded. So it is possible that supporting data for final potency assays for Rex. may have been asked for.

Take what the FDA has done up to date. They did not approve GVHD due to final potency assay and I doubt that they could for Rex. with out contradicting themselves.
We know that they agree in principle for the potency assays for Remestemcell-L. SI is putting the supporting data to the FDA by submitting a new BLA.

FDA basically postponed this requirement for the CLBP application by requiring a second study to be completed. I was disappointed as I felt that the data was very compelling for accelerated approval however given that they agreed on the 12 month primary end point I can understand thire decision.

But for CHF they may be saying " Give us what you have re potency assays and we will assess wether the data is sufficient for a accelerated approval pathway.

If this is what has happened it would suggest that the CHF efficacy data has past the standard for accelerated approval.

News from the FDA will be huge , investors are obviously hanging out on FDA responses. Take a look at Bluebird Bio. Those SP movements would be minimal compaird to positive outcomes from the FDA for MSB.

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Bluebird Bio is down 78% over the last 12 months....

MSB Price at posting: 69.5¢ Sentiment: Hold Disclosure: Held
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