"Good vibes Here Dudes"....., page-27

I think Cynata correctly forecast the latest knock back by the FDA.

Really? Where did any Cynata official. Kilian or anyone else forecast the latest knock back - I must have missed that.

My impression (which could be wrong - and demonstrably so - if you can give me a quote from a CYP official before the CRL or anyone can) is that CYP was not making explicit predictions.

I vaguely recall KK saying something like approval of an MSC therapy would be benefit for the field - but perhaps it was just someone reporting him to have said something like that.

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This second comment is just btw and is unrelated - the split on proposed phase 2 GvHD trial between control arm and treatment arm doesn't seem to be in the clinical trial design - I believe it has been described previously as a 40 20 split (40 treatment and 20 control) was what I originally thought was proposed - but when Ross spoke with Stuart Roberts I think he described a 30 30 split.

Personally I would like to know what the split is - 40 20 or 30 30.

I do not know if KK is correct about it being a possibility that a p2 trial that is good enough could make a p3 unnecessary (relying on your now twice posted reference to KKs statement on * - pledge) but I do think it matters a lot that the trial design be extemely robust. I hate that the split between 40 20 or 30 30 for instance is not pinned down.

Patients will go into trials on the advice of their doctors and doctors will advice patients (or should do) with a mind for what is in the best interest of their patients. The doctor and the patient would want to know what the risks are.

If I had GvHD right now, or someone I cared about, and there was choice between different clinical trial protocols that I might enrol in, I would have a preference for a trial that had mesenchymal stem cells as part of the trial - because I do think, based on what I've read that MSCs do do something.

But I wouldn't care much whether they were CYP MSCs or Mesoblast MSCs provided that they were potent.

Give me a choice between an MSC trial - with no chance of not getting MSCs and a CYP trial with either a half or a third chance of not getting MSCs and I would have a preference.

I think I know a lot more about MSCs than most people with GvHD would. But there is a lot of stuff I don't know.

I don't for instance currently know if there is a real difference between HR-GVHD and SR-GvHD - I see that pfeifer is suggesting there is - and he is more likely to be right than wrong in m experience of him and more likely to be right with research than I am with no research - but I haven't researched that yet. I don't know if there really is a difference between HR-GVHD and SR-GVHD but I'd like to.