Cell Therapy News/Articles, page-14422

Thank you for your response LearningEachDay.

I'm fully aware of that fact.

My point is that, had it been Pfizer or Merck or Novartis that owned remestemcel-L, and they had received a 9 to 1 vote in favour of approval from ODAC, what do you think their chances would have been of getting it approved there and then? A bit bigger than MSB's I would think. That's an opinion of course, and we'll never know.

As an aside, generally speaking, there should be no difference in what standard, products seeking approval, should be held to, "first in class" treatment or not. They should all firstly be safe, and then secondly, effective. While the specifics of how you determine that may differ for a drug or biologic, the standard products are held to, should not differ. That goes back to my earlier point about consistency and fairness. Meanwhile, back in the real world ......