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The other MSC company has received FDA success for ALL P2 trials...

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07/03/24

18:10

Post #: 72799752
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Originally posted by GH1971: ↑

Not saying it's easy, but the other MSC company has some very specific issues also. Leaving those aside, we do have the benefit of their experience and can learn from it. Walking in the footsteps of giants is a fairly sensible thing to do, if those footsteps lead into a minefield.

And given history I'd rather have Iqvia running our trials for us than CYP management doing it... They have much more experience and, one would hope, competence at it.

With respect to costs on the trial, from a previous Q&A session that was held with Ross he was saying that cost is primarily driven by the the number of sites because of all that goes into getting ethics approval, then initiation and training at each. Particularly with a short treatment trial such as this (though he was talking about MEND at the time). The cost isn't really driven by number of patients unless you have extremely high product costs. The patient being treated in the hospital would be there anyway, as would the doctors, nurses, orderlies etc. Those aren't costs of the trial, they're already there in the health system. The incremental trial costs in the hospital are provision of product and data recording so additional patients treated at the same site are generally very low cost.

That's the trade off they have to weigh up in conducting a trial - opening up additional sites to speed up recruitment (if that's slow) will blow out the cost.

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The other MSC company has received FDA success for ALL P2 trials they conducted. Stellar results.

They did each of them economically and successfully. That’s not my opinion, it’s historical fact.

CYP Price at posting: 19.0¢ Sentiment: None Disclosure: Not Held
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The other MSC company has received FDA success for ALL P2 trials...

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The other MSC company has received FDA success for ALL P2 trials...

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