The Phase I/IIb Nereid Study Is Now Registered, page-19

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JB1975

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21/03/24

12:04

Post #: 72992639
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Originally posted by JB1975: ↑

You wrote
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"considerably less" & "more homogeneous"

She came to the conclusion there will still be a difference, but the smaller the differences, the more predictable and reproducable the clinical effect in the target population.

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---all the above I can grant as being true - but the considerably less and more homogenous are phrases that relate to the alternatives - they don't absolutely establish that our cyp cells will be homogenous enough to be effective in patients - I think you'd agree with that (phase 1 though was promising) - I think you like me realise the trials have to establish that (that the cells work - so they are homogenous enough to meet the criteria of working in patients) in a statistical significant way. (The Sculptor trial should be really good science when it eventually lands - because of its size of patient-pool but it is plausible it might not show a significant benefit in my opinion - I think that would be David Hunters view as well - I think he is looking to see and is perhaps even quietly hopeful to see good results but is too good a scientist to prematurely presume good results (like say Dr Joanne Kurtzberg apparently does) I also think like me you would weigh the large amount of mesenchymal stem cell data from many trials (including Osiris) with MSCs generally and conclude all that signal can't be just smoke. MSCs are doing something (almost certainly - at least sometimes).

This reply to you isn't very deep - I'm about to agree with @Pledge on something - I agree with him that he is not trolling (bedger does not speak for everyone) merely by doubting that CYP has sufficient funding for the phase 2 - its on the directors to build confidence they have have sufficient funding by clarifying and providing sufficient detail in my opinon, their history is not one that inspires trust in their calls or in their reading of the market, quite to the contrary in my view.

I do agree with Truss20 that pledge has stressed the need for in country offices in the US, and that doesn't seem so far to be the case, nor in my opinion was it ever the case, HOWEVER, cyp, Kilian and Brookes etc do seem to have essentially outsourced a large part of the management of the trial to trial managing third parties - making me think what are we paying those guys for - to hire third parties on shareholders behalf?

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Found this note I'd made (on the base slide which is from MHG's presentation) which goes to heterogeneity / homogeneity - ie. that its not black and white but some shade of grey instead even for CYP cells.

This slide clearly shows both that the cyp cells are more homogeneous (or less heterogeneous than cells from other sources) --- however they are not completely homogenous - begging the question how homogenous is going to be homogenous enough - which is likely to matter especially in trials with small sample sizes perhaps like diabetic foot ulcer. Will the sample size for DFU be sufficient to detect an effect if the effect is real but not overwhelming (through being completely reliable (through homogeneous cells acting on a homogeneous disease type) or not?

I don't know.

CYP Price at posting: 17.0¢ Sentiment: Hold Disclosure: Held
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0 Great analysis

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