Ann: First Patient Treated in Phase 2 GvHD Trial, page-41

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truss20

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22/03/24

12:43

Post #: 73012531
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Originally posted by JB1975: ↑

Replying to you because your post is recent with a trial link.

I still think it matters what the breakdown of treatment to control arm is - is it 30 and 30 or 40 and 20? Are they trying to keep that split as something they can change because they haven't specified it explicitly - say its harder to recruit - I hope not.

With 30 centres aimed at (I think I read that is a link to commentary by KK you found pledge) thats only 2 per centre on average for the 60 (though they don't even have a hard commitment on 60 (I get it (truss20 most likely to observe that) statisticians (DSMB etc) are supposed to be reviewing as things go along -- - but is a lot of potentially different locations - which can sometimes introduce other variables.

Pledge - no one, that I can see is essentially disagreeing with you that it is not guraranteed that CYP has enough cash to complete the trial as planned.

I will be very pleasantly surprised (because its against the clear long pattern of performance and because management haven't released anything like sufficient detail to give confidence that this time is different) if they actually complete recruitment by the end of the year.

Europe is important to have approval for - but Europe and GvHD has been notoriously difficult a collection of places to recruit in - for example the RETHRIM trials got mentioned at MSB's ODAC by one of the visiting experts showing how hard it was to recruit - for kids - in europe - with the different country by country requirements). This is not kids. That may help. But Europe had some really whacky laws - Italians - Catholics - strange country by country cultural attributes to when life begins and contraception etc effecting the laws from memory.

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"I still think it matters what the breakdown of treatment to control arm is - is it 30 and 30 or 40 and 20?"

This has been addressed by the company - it is 30 and 30.

"but is a lot of potentially different locations - which can sometimes introduce other variables."

I'm not aware of a GvHD trial where the number of locations used has been a consideration in approving or rejecting a clinical product. IMO it is an accepted reality that patients have to be recruited from a wide range of different locations as the condition is so rare.

"I will be very pleasantly surprised...if they actually complete recruitment by the end of the year"

Me too. Consider that recruitment is expected to complete this calendar year, but results are not expected until H2 2025...despite the endpoints being at 100 days (just over 3 months). Either they're planning to over-deliver with on-time recruitment and early results, or miss the recruitment time-frame but meet the results guidance. A bit of a bet each-way IMO.

CYP Price at posting: 19.0¢ Sentiment: Buy Disclosure: Held
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