You are what iffing here far too much as one of the other posters said.
Did you know with absolute 100% certainty that MSB was going to use TNFR1 as part of their potency assay prior to the ODAC where details became public knowledge. If you did not know absolutely 100%, it's because the company does not release trade secrets. I did not know. Please enlighten us with the source document that explicitly stated they will use it.
If you didn't know, then your comment about the company should tell everyone the exact process they are using for FDA approval is absurd. The FACT is that while tests have been done with both TNFR1 and INF gamma, to show they might work against gvhd you have no proof whatsoever that us the case. If you had proof then Remestemcel-L would allready be approved. Nobody has the proof.
Every competitor on earth that hears msb has great correlation using inf gamma plus tnfr1 to treat gvhd will start looking at it themselves, because nobody has that treatment data using mscs in that many patients except msb. It's just plain corporate business ethics. KFC don't release their secret herbs and spices because it's known that you can get a similar taste using x y z.
regarding your never ending whatifs.. whatif they use 10 donors, and they were all outliers? Whatif the number was 20 or 50 or 100, or 1000 and then it stops working? What if race has something to do with it, or gender, or age, or fitness. Whatif they use inf gamma plus tnfr1 and then that stops working. Whatif they include IDO also and the three of them stop working ?
You can basically tack the question whatif on the back of the most compelling medical data to try and discredit it, but that is not how medical trials work.
They have reached clinically meaningful end points with high probability values repeatedly , and have this as evidence of efficacy. You cant then - without a single shred of evidence suggest that the efficacy evidence is all false because you suggest something else might work better - that has not been proven at all.
inf gamma - where is the proof it is linked and improved mortality in gvhd trials
- where is the proof they are or are not using it
We already know we are about to get more proof about the whatiff the 3 donors were outliers, from the eap on 240 plus children.
but again
... what if one day the ingredient supplier for panadol needs to change to another supplier ?
simple - monitor the results for continuous improvement.
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