I only ever said that Redectane was the biggest turnaround I had...

I only ever said that Redectane was the biggest turnaround I had witnessed from an ODAC vote to the final FDA decision and shows that no matter how strong the panel vote may be, it doesn't assure approval.

As a one on one comparison, no it is not one that you would argue, I agree with you on that completel, but I have never said that it was. What Redectane does to tell you is that the FDA doesn't always agree with the panel, even when the panel vote is overwhelming. If the FDA were truly concerned about Redectane's safety, they would've put it to a vote or kicked it much earlier. In the end, they kicked Redectane on a trial design flaw. They were about 10 patients shy of what they needed, from memory, to fit within the FDA rules.

As I said, if you want proof that a positive panel vote doesn't equal approval on the first cycle, look at sipuleucel-t - a cell therapy, panel vote positive, FDA thumbs down. Three years later, they finally scraped enough together, to get the FDA's nod. It was a very big one at the time because it was the first cell therapy and cancer vaccine to make it that far. Information about it is easily found. Have a look.

BTW, the FDA changes very, very, very slowly. It took them 10 years to formalize deciding not to send companies "not approvable", but complete response letters instead. The basics of the way clinical trials should be conducted and the data examined are almost nailed to the floor. Yes, there have been changes at the FDA, as the introduction of Breakthrough Therapy Designations is a major example. Committee meetings remain pretty much completely the same, as they were back then, though. Not every drug, therapy, or PMA application goes to a panel. They run them when the FDA has some doubts and wants to cover its proverbial.

I am not arguing here that remestemcel-L is going to get a CRL. All I am arguing is that there is a chance it won't get through on the first cycle, like sipuleucel-t.

Why you want argue about stuff that I haven't said is beyond me. My posts aren't going to make one bit of damn difference to the way the FDA views things or to MSB's share price.