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Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-278

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08/08/20

15:34

Post #: 46398636
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Originally posted by Southoz: ↑

Well don’t let me discourage anyone from having a crack at putting something together. It will be interesting to see what the hive mind of HC can come up with.

But my 2 cents worth would be that the die is well and truly cast here.

I don’t think the critique from Lassman contains anything the FDA wouldn’t have already been aware of. The main surprise to me was that the key weakness in the historical P3 trial was not picked up when it was published in the Journal of Biology of Blood and Marrow Transplantation.

The critical weakness in MSBs case is that P3 historical control group trial.

The 45% OR for the historical control estimate (on which everything depends) is plucked out of thin air. In the paper the justification tucked away in the Supplementary Material section of the paper. The estimate unravels (as Lassman found) within two seconds of looking at the four papers cited in support of it.

This should never have got through the journal peer review – and the invited commentary – without being picked up.

But all is not lost because MSB have a cunning plan. There is a fourth study which only MSB and the FDA have seen the details of.

MSB generated new data to bolster the weakness in the 45% historical control estimate. So there is a new estimate (more rigorously derived) from the Mount Sinai Acute GVHD International Consortium (MAGIC).

MSB hopes this provides “an unbiased and independent estimate of response rates and outcomes in matched pediatric control patients treated with institutional standard of care”.

The MAGIC bit is aptly named.

So whats going to happen?

My hunch is it will be more about psychology than clinical trial methodology. And will come down to the communication between MSB and the FDA around the design of that P3 trial.

If the FDA were supportive of the plan to use a historical control group because of the ethical / logistical problems, then there is a flavour that MSB have done what was asked of them.

If on the other hand the FDA were lukewarm or even negative, then there is a flavour that MSB are simply trying it on. And MAGIC doesn’t substitute for doing the P3 trial properly with a parallel control group.

If I had to take a punt, I would guess that cunning plans are usually hatched after your main plan is derailed. And that the FDA were in fact pretty lukewarm towards the historical control group design in the P3 trial.

But we shall see. If my nose is pointing me the right way the AdCom meeting will be a huge anti-climax. You will know the outcome pretty much from the FDA briefing notes where that communication around the design of the P3 trial will be outlined.

Expand

If the FDA were negative on the use of a historical control group arm and intended to use it for rejection of Ryoncil, why approve the trial in the first place?

MSB Price at posting: $4.40 Sentiment: Buy Disclosure: Held
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