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Bold you, below me)
At the level I was talking one organ being transplanted and facing rejection is pretty much the same as another [...]You criticise the high level explanations a la KK, RM and SI, as it (and I agree) lacks detail and leaves a lot of room for misinterpretation (more often than not on purpose). Yet, "the level" you chose in this instance is not a case of "same same" rather "but different". Had it been (in this case) the CYP leaders making the call on trial protocol - but it was Leiden University, which brings me to the main reason for strongly objecting to your post. Leiden University is not specialised in lung transplants, but kidneys. And the people involved at Leiden - have a clinical trial record in CKD in conjunction with MSCs:
2009
https://clinicaltrials.gov/study/NCT0073439615 patients, non-randomized, single group assignment, autologous bmMSC - completed.
2015 The Neptune Study
https://clinicaltrials.gov/study/NCT0238715110 patients, single group assignment, allogeneic bmMSC - completed.
"Taken together, allogeneic MSC may be an important treatment option for recipients of a renal transplant, especially for indications where autologous MSCs can-not be realized logistically. We however believe, that we should accurately study the immune response and inci-dence of allograft rejection, which could be elicited by allogeneic MSCs, before we move on to larger studies."
https://www.researchgate.net/publication/283521117_Safety_of_allogeneic_bone_marrow_derived_mesenchymal_stromal_cell_therapy_in_renal_transplant_recipients_The_neptune_study2014 The Triton Study
https://clinicaltrials.gov/study/NCT0205796570 patients, randomized, parallel assignment, autologous bmMSC - active, not recruiting. 57 patients included in final analysis and only one patient in MSC group received one MSC dose (due to COVID-19), while the remaining 28 in the MSC group received both doses.
Both groups achieved similar fibrosis scores, hence study failed to meet its Primary Endpoint.
"At present, randomized trials with MSCs are still very limited and the field is only slowly advancing also due to stringent regulatory requirements, the need for clinical grade cell production facilities, and the associated costs. However, we recently also reported the feasibility of administration of third‐party “off‐the‐shelf” MSCs in kidney transplant recipients. 11 This option makes manufacturing and regulation easier and the use of MSC suitable for a wider spectrum of clinical application and much more feasible. We believe that the results of our current trial set the stage for the next steps and use of MSCs in the field of kidney transplantation to reduce the need for excessive use of clinical immunosuppressants."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518640/I find it interesting how the results were assessed and used in the development of the protocol for the next trial and/or results were compared, as opposed to "throw it all against a wall and see what sticks" aka subgroup analysis. I mean, what's the point for example in running a large trial say in GvHD with hundreds of clients, to then end up with a subgroup analysis in a fraction of the hundreds, where the data is not enough to convince regulators such as, don't know, say the FDA, to deny a BLA application times x. This is the 21st Century afterall and leaders do on occasion learn their lessons.
Coming back to our Nereid Study, "
"LUMC has conducted 3 trials using bone-marrow derived mesenchymal stromal cells (BM-MSC) showing both safety andefficacy of their use in the setting of kidney transplantation.MSC isolation and culture from both autologous and allogeneic sources is being hampered by cellular heterogeneity and replicative senescence. Generation ofMSC from induced pluripotent stem cells (iPSC) so called MCA-derived MSC may circumvent these limitations. MCA-derived MSC have recently been tested inclinical trials and found to be safe and more cost effective than traditional MSC. Given the benefits of MCA-derived MSC we propose to test whetherMCA-derived MSC are safe in the setting of kidney transplantation in a clinical study. The TRITON study in which MSC therapy was shown to allow withdrawal ofthe nephrotoxic calcineurin inhibitor tacrolimus, will form the backbone forthis clinical trial in which 16 patients will receive MCA-derived MSC combinedwith tacrolimus reduction to study safety and immunological efficacy ofMCA-derived MSC therapy."
https://onderzoekmetmensen.nl/en/trial/53310At 28 cents (I think the rise is on low volume in a traded stock - traded by dim wits and MSB fear of missing out - nearology players - hey MSB is going up so CYP should too) the new Chief Partnership officer is nearly in the money with his 29 cent options and he hasn't done or said publicly a damn thing. The idiots in the marketplace are rewarding idiots on management boards and leading companies.Investors (not scientists) buying low and selling high(er) are not dim wits. Whilst understanding the science gives you and edge like you did when you predicted the second CRL, your reservations in management and their history prevented you from investing in said stocks at 11c, 12c etc. and 28c, 30c etc. The dim wits are the ones selling at these levels, and sadly, that also includes myself as I was forced to sell a few CYP shares at an average of 13.5c with a cost obviously higher than that (due to health reasons, but that's not the point). The ones reading the market, using TA (or pure luck, also besides the point) on the other hand doubled/tripled their investment. They may not share the same passion for the underlying science like yourself, but ended up with a satisfying financial benefit, not the "dimmest" thing in a world led by capitalists. Congratulations (again) to buyers in both CYP and MSB at the previous low SPs. And the ones participating in the last CRs, that also ended up with options (that's where I now almost redeemed myself), I am looking forward to you converting your options and adding funds to the company bank account. Whilst it is annoying that investors had to take a significant financial risk to be rewarded, when the new CPO simply had to sit back and sip on his cold Hefeweizen and enjoy his pork knuckles, I hope (here's that ugly word again that is of no use when it comes to investing) that he is motivated enough to so his options grow to minimise any "damage" if he intends to benefit from a cashless exercise in the future (if that is still allowed, haven't checked, but am aware of KK doing that a few years back).
What has Kilian done since replacing Ross?The communication with shareholders has improved. Interim results in DFU (although I didn't agree with the timepoint chosen as it seemed random) and updating recruitment numbers in our quarterlies. That is something that should have been done years ago. Instead shareholders were fed excuses about strict ASX regulations etc.
Is there room for improvement - sure, there's always room for improvement. But he still has my support. Lets wait for his first Kohler interview and see if he passes that. Until then, lets measure him on the upcoming DFU results which have his handwriting all over them. And of course GvHD, that's also him. On the other hand, MEND did, too. But give him some time wearing suit and tie instead of a lab coat, let him present new clinical data, a clinical study report and see how he does, see if he remembers to switch on his microphone during presentations or if he should still be putting training wheels on his bike, in which case I will join you chasing him through the village (verbally). Until then, lets appreciate that we went from 10.5c to a yearly high of 29c.
In this spirit, "To Infinity and Beyond!"
Please check my OnlyFans account and Tiprank score before following my opinion above:
https://www.tipranks.com/experts/bloggers/pfeifer1982
(20min delay)