I usually sit on the sidelines amused by the posts of others but felt the need to provide my thoughts. I apologize in advance for the length of this post. It seems to me that the recent PR has been misinterpreted or at the very least over interpreted, and the share price has suffered accordingly. Consider the following:
1. The PR only states that additional safety data is needed in a GLP laboratory. It did not state that prior work was not conducted in a GLP laboratory.
2. The FDA has known from initial application where all data was generated (GLP laboratory or not). They clearly found prior data submissions credible or would not have allowed the application process to proceed.
3. The true test of a scientific study is repeatable results by independent researchers. The initial data was either accurate or not, and this should be easily demonstrated. One can argue the integrity of Dr. Koos, but to think the other researchers involved would risk reputations providing inaccurate or false data is conspiratorial at best.
My background is medical, and I previously taught at the university level. I have not written an NIH grant, but I have written other research grants, published in peer-reviewed scientific journals, written book chapters, and provided limited consultation for at least three GLP laboratories in two states. I am not detailing my background to sound pretentious, rather to make the point that I have read several of Dr. Ichim’s and Min’s publications and can understand them. I suspect that many contributing posts on this board cannot. These individuals appear to be reputable and are published in prestigious journals, which is no small task. If additional data is needed so be it. If prior data was accurate, it will soon be reaffirmed and simply strengthen the application. The delay in FDA approval is frustrating, but I believe approval is inevitable. I would be disappointed to lose money thus far invested, but I do not require an immediate return on this investment and believe it will ultimately be worthwhile. Just my opinion, but I have faith in the science.
