I would suggest that our P3 trials were designed to confirm the hypothesis , inflammation is the key to both disease severity and treatment success. For all the noise of failed P3 trials seems fairly significant to have very high response rates resulting in astonishing benefit to the patients in all our cell therapy trials .
I see that some still question wether FDA will except our potency assays despite them been agreed too in principle, supporting data been given to OTAC and MSB moving forward testing current stock for commercial release and validation of the testing procedure.
Well maybe FDA could raise the bar yet again.
With the substantial data we now have for efficacy I highly doubt that FDA would require a higher level of confidence in our product. It would actually be more likely they lower the bar as it becomes more obvious that a lot not performing would quickly be identified through annalases of real world data.
We also here that MSB should have had the potency assay sorted before any clinical data, yet now that we have mountains of data we will need further trials to establish those assays.
Now for today's results, we are told nothing new here yet the other day SI was misleading and had miss spoken .
The data released today seems to confirm all that SI has said. The only question I would think remains to be answered.
Why is this data been released now?
SI is a smart man , he knows how to protect the companies interests. For some reason this data was been held and now has been released. My view is something major is likely to be released very shortly. FDA feedback could make reference to this data.
A potential partner may also want to release this as part of a announcement to the market . Or it may simply be a release through a published review.
Great day and better to come ,
Good luck all.
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