@Techinvestor
I agree, @dachopper, that TechInvestor’s view may be simplistic and overlooks all the insights which would have been accumulated by the company over the course of the trials. From the greater understanding and use of biomarker information about inflammation of patients, it should more clearly be able to distinguish responders from non-responders upfront, as discussed in the cell therapy Jun 2023 landscape survey article linked in one of today’s posts above. Knowing who to target appears to be key to the success of the MSC therapies as alluded to in the article.
In addition, the company announced interim results from the Cleveland Hospital IBD study on Crohns and ulcerative colitis, conducted by Dr. Amy Lightner and later published, in early 2022. In a 2020 announcement on the trial’s commencement, Dr. Grossman mentioned the similar presentation of symptoms in GI GVHD and some IBD. As such, the IBD trial information would also inform the company’s assessment of its confidence in the pilot study it said it had done on adult GVHD and the idea that an adult study would be the 10% of work it needs to do to lead to approval.
Pragmatism and corporate memory demand that Dr. Itescu should continue to lead the company at this time. I emailed him in the past about succession planning and bench strength. I don’t think he is not aware of these very important governance questions, but now is not the best time to be fixated on them.
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