"[...] but if you have a batch of MSCs that for any reason increase the INF gamma levels when they are added (in vitro) to a mix and then you see interferon gamma levels in the mix go up - then something is going wrong. You've got a batch of product that is actually acting counter too what you want on the interferon gamma dimension which is a cytokine storm component.
If I recall correctly you have previously found in my comments with dachopper an example of me showing that MSBs own data shows that inf gamma increased on at least one occasion the measured levels of interferon gamma."
That's exactly what I was referring to. The issue you have highlighted between CRL #1 and CRL #2 as being at least one confounding factor that was in the absence of a well-controlled trial what led the FDA to overrule the 9-1 ODAC recommendation. If the FDA had been convinced that the trial was well-controlled, I dare say they would have approved it at the time.
CRL #2 and still without a well-controlled but supposedly new clinical data (same data but sliced differently), was again not enough to convince the FDA and again, you correctly and this time before the CRL pointed at the slide showing interferon gamma levels to increase when you'd expect them to reduce (it was one batch of five from five different donors if I recall correctly), and given that the slicing has turned the clinical data into pieces simply too small to overpower the FDA's previous concerns, it wasn't enough to gain approval. Again, had the trial been well-controlled in the eyes of the FDA, we likely wouldn't be talking about this in 2024.
Now I think the FDA has agreed that the trial in hindsight could be considered well-controlled given the emphasis in MSB's releases (or at least that is MSB's interpretation), and with the primary endpoint being met, plus improvements made to the potency assay they have "reverted back" to and a demonstrated intention to obtain more data with a partner like BM CTN lined up, I believe that this time the FDA will approve it, albeit likely conditional. That is an opinion - mine. Nothing else. No financial benefit on my end either since I am not invested in MSB.
No face to save, no beauty pageant or popularity contest to be won, just acknowledging shareholders sticking to their guns, buying shares during ATL and participating in a Cap Raise at a time when they could have bought them cheaper on market, to now have options that are in the money and worth more than the SP saving at the time if bought on market, I call that in hindsight a great financial decision or at the very least a very lucky punt. Either way, money has been made and for that, well done. That is separate to the issues you have highlighted before CRL #2 and copped a lot of hate for. For sticking to your guns at the time and taking the time to explain your reasoning more than once, being told you can't call Dr Kurtzberg Dr Joanne and Professor Itescu simply by his last name despite it being common practice and acceptable if your opinion agrees with the overall positive sentiment - because it was easier to attack you as a poster or your posting style instead of dealing with the argument you ha e presented, I congratulated you as well and have since been paying even more attention to your posts and the level of detail in your posts you are willing to share and I look forward to reading more as I take it on board with my investment as well.
My beautiful face is not in danger and doesn't require to be saved. Not yesterday, not today and hopefully not tomorrow either. But I appreciate the concern and am considering a GoFundMe page in case anyone is interested.
No ticks needed as this post doesn't contain anything useful and I couldnt even be bothered proofreading it. Thank you.
(20min delay)
