Here's some links to the referenced science studies. These are references 1 and 2. Full text does seem to be available - I haven't read them yet. Or perhaps I have read the second one and forgotten about it.
Autologous bone marrow-derived mesenchymal stromal cell therapy withearly tacrolimus withdrawal: The randomizedprospective,single-center, open-label TRITON study.
From the announcement text "Cynata will supply iPSC-derived Cmerus mesenchymal stem cells (MSCs) at its cost to facilitate the trial" - that is not unreasonable, indeed the alternative almost would be given "and has full commercial rights", (in a partnership you bring something to get something from your partner that is better than either can do alone) but CYP doesn't have unlimited money or unlimited cells at the cost of their manufacturing to us. Remember what we paid to Waisman. Circa a million from memory. So far as I know the FDA still has our cells on 2 year usage clocks. Leiden, Netherlands, is Europe not the United States so could be some differences potentially in terms of how log the shelf life on MSCs are in Europe for research stage medicines like cells in cryostorage - I don't know the answer to that. So I'm not fear mongering but being realistic and cautionary - even the cells that we provide we have to be cost mindful about because we pay a lot (compared to our cash on hand and our market cap) to get them manufactured.
And its not foolish or downramping to be concerned about the useful life of CYPs patents and what that means for commerical deals that rely on those same patents being active patents.
So I'd like to know what the costs to CYP actually are - even accepting as I do that the deal cells for commercial rights looks fair and positive on its face.
"..will be lead by Prof, Ton Rabelink, Head of the Department of Internal Medicine of LUMC and will seek to recruit 10 patients who have undergone a renal transplant."
10 doesn't sound like a lot and I think an expert in the field of renal transplants might foresee based on historical trends with some degree of confidence that there is going to be 10 available if he can convince them to go for the trial ---- but I am still concerned about trial recruitment models that seems to see CYP committing funds to commencing trials (like start with a few hospitals) without greater confidence that the trial numbers will ever be reached.
I don't want to overstate the point but the words "seek to recruit" both concern me *we'll put up cells regardless - presumably they'll be in Europe, in the Netherlands ready for use, and we may not get 10 patients, I gotta say I do think we probably will though to be fair. I feel more confident about getting 10 for this (when there's a motivated research partner with expertise in the location and the number is only 10) than I do about getting 60 on p2. They concern me, but on the other hand I acknowledge that even mentioning "seek to recruit" suggests CYP might have learned something about checking recruiting numbers from their MEND experience.
With p2 in GvHD, is CYP going to have the bargaining power to say to institutions, centres that treat cancers etc, (some of which will need to be in the US in my opinion - I think the FDA will want some in the US) we want you to work with us on our trial to help us recruit patients for our 60, but we won't commit to doing a trial until we see good chances of getting the 60 or is CYP going to effectively run a risk of doing the trial, starting it rather, getting ethics approvals in centre 1 and centre 2 say, with just one or two or a few centres on board that can't deliver the 60 but will get them a start towards that target.
The planning of the workflow matters for the management of costs. It really is better not to spend money on a trial that cannot recruit - and I don't care if there is a traditional way that things are done in setting up trials in this space - if the traditional way is not commercial - screw the traditional way and do things the commercial way, is my opinion.
CYP Price at posting:
29.5¢ Sentiment: Hold Disclosure: Held
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