BMSN - What the FDA hold up is all about >> READ
I am getting the same question from a few people about BMSN so I will post my comments here.
My thoughts on BMSN have not changed since I last posted this forum. What I want to see (and I'm sure the FDA is looking for the same) with BMSN is for them to increase the size of their study. I had commented months ago that a study size of 10 has its problems, the biggest one being that it would not return a reliable p-value. We look for results that are statistically reliable, and when we're dealing with such a small number like ten, results derived from this small number cannot reflect a larger pool of people. On this basis, I wanted to see the study size to be increased to at least 50 or 100 if possible.
Having an IND application number means nothing, folks. If you submit an application, you are assigned an IND number. You really have to question why it is taking so long for the FDA to give a green light on starting the clinical trial. They see what I see, and there will be more going back and forth with the FDA on the application. Regen/BMSN can cure this deficiency by increasing the study size, it's very simple.
If HemaXellerate were the blockbuster that Regen/BMSN touts it to be, they really should consider doing a study with a realistic and believable study size.
I would watch this develop, nonetheless.
Good luck all
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