If you are referring to Exogenous endothelial cells as accelerators of hematopoietic reconstitution, yes I have read. Based on the 'data' contained in the review, it would appear that Regen could be doing a two-sided test here using either a comparison of two proportions or two means wherein we can assume level of significance at 5%, power at 80%.
So, we are looking at either this formula here:
n = [(Za/2 + Zß)2 × {(p1 (1-p1) + (p2 (1-p2))}]/(p1 - p2)2
or this formula here:
n = [(Za/2 + Zß)2 × {2(ó)2}]/ (µ1 - µ2)2
Doesn't matter what type of comparison is done here, n does not equal 10 and requires a bigger size unless they are basing their study size on a totally different set of data that we have not been made aware of.
I am wondering why it is such a big secret to let investors know what they are looking to measure, what data we are to look at for comparison other than this review.
At any rate, since folks generally like to ignore constructive views of others and scream going to $10 instead, I will preclude posting.
Even if this IND application involving 10 subjects were a safety study, the FDA requires a clinical trial plan (aka clinical trial protocol)that includes the objective of trial, primary and secondary end-point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, statistical methods and assumptions. One of the key aspects of this protocol is sample size estimation.
Until the FDA is satisfied and finds the sample size to be adequate, there will be no green light here. Take it from a poster whose moniker is "buybio", been doing this 20 years.
At any rate, just chiming in. No need for the forum to get all worked up...don't want people calling me a 'basher' now, do I? LOL.
Have a great evening and good luck all. I have nothing further to add at this time.
Ciao
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