So , what have I missed ?
Safty ?
Its not a bad problem as if it was the trial would be stoped how ever the way the results are put together the patients that have had a advers advent could significatly effect the headline result. I am not disputing the headline result. It is good.
Before the claim " the cells work" can be made
( somthing all investors would like to see) a change in the trial desighn is needed.
Treat the control with the same unseeded dressing and enroll a lot more patients as the dressing without been seeded could provide most of this benefit. To carry on as planed is waisting time and money.
Ann: Encouraging Initial Data from CYP-006TK DFU Trial, page-35
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