Goooooooooood Mornin', ya'll! It is a fine Friday
Post# of 5066
Goooooooooood Mornin', ya'll! It is a fine Friday morning here near the banks of the beautiful Chesapeake Bay. I do hope most of you are feeling as grand as I am this morning and that you are steadfast in filling your heeds with useful knowledge!
And here is some to get you started:
As mentioned in the PR provided by our beloved BMSN on 31 July, the company has submitted the requested information, providing data to further show the efficacy of HemaXellerate (remember, now, safety is no longer a concern. Further testament that it works was requested). Remember now, the information has already been submitted. So what does that mean? Well, in my humble yet somewhat educated opinion, if you have a gander at the below chart, the good doctors (and that includes Dr. Koos, now!) adequately substantiated their efficacy claim. Or, translated, they have shown that the treatment is indeed very much effective!
Moreover, as I have outlined previously, unlike the vast majority of treatments under scrutiny during trials, monitoring the changes within the patient from the HemaXellerate treatment (also known as success as far as this gal is concerned) takes but a fraction of the time due to the very nature of the treatment. Please note the remarkable changes after just fourteen days.
Just look at the significant improvement in white cell count and the marrow healing (regeneration) with the HemaXellerate versus that of the placebo!
Ain't that about the pertiest thing you ever did see???
If you go digging deep enough, you are bound to find what you are looking for: this data predates 17 July. By how many days I do not know. A week maybe? A couple of days? Not sure. But certainly not more than a month.
And what exactly is PG getting at? Well, that is has been more than two weeks since the good docs at Bio-Matrix Scientific group submitted to the FDA the PROOF that HemaXellerate works!
Quote:
Based on experiments that FDA requested , the company generated new data further demonstrating efficacy of HemaXellerate I™ in animal models. This may be seen in the figure attached.
Further, some have queried about the following, asking my opinion:
Quote:
Regen BioPharma has assembled a team of key opinion leaders in the area of adipose stem cells, which have previously reported the scientific basis for HemaXellerate in a peer-reviewed publication www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf. The company is currently working with these key opinion leaders to address the FDA's comments.
Does this really mean it could be months before an approval is provided? No! The above does not necessarily mean that. The above may very well mean that there are some FDA instructions to be carried out during the course of trials and how to correctly/sufficiently apply these instructions during trials.
They are doing everything right and all they can!
There is no talk of a R/S that I am aware of. I am pretty sure that is just hogwash.
Go, Go, Go BMSN!
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