Inventor, It's phrases like this that worry me
Post# of 5066
It's phrases like this that worry me the most:
Quote:
And after a few very minor and simplistic questions are answered regarding safety I believe we will achieve the FDA stage one status (with orphan drug status )that we are all looking for.
If it was all so minor and simplistic, why have 6 weeks passed since the May 12 PR and it's statement that the IND was updated and resubmitted on May 9th? In the May 12th PR, the following statement was made:
"Given the HemaXellerate I™ product is derived from the patient's own fat tissue, and numerous key opinion leaders support clinical entry of our product, as demonstrated by our peer reviewed publication http://www.translational-medicine.com/content...0-231.pdf., we are confident the safety studies the FDA requested clarification on can be addressed in a timely fashion," stated Thomas Ichim, Regen's Chief Scientific Officer and Board Member."
Or maybe you are saying that after the FDA reviewed the May 9th IND update, there are still a few questions remaining that do not endeavor complex or new trial data.
My main concern, having over invested in BMSN in the past year and a half based on PRs and potential is that the timelines and time frames released in PRs cannot be depended on and the PRs do not release all the bad or negative news in true transparency. This makes investors nervous and we tend to lose trust.
I would much prefer that the May 12th PR would have stated clearly both the positive approvals of protocol and manufacturing and the negative, what was not approved, why and what the company anticipated doing in response along with a time frame in order to obtain full approval.
This is what established companies do. Would the stock drop temporarily, sure, but if Koos isn't selling, then it would not be a concern for him and as an investor, I can anticipate whether to sell and repurchase, hold and buy more lower etc. Then when the anticipated time frame was nearing completion, people return to the stock, price goes back up and success would relaunch higher, all with objectivity. Without transparency, we are at the mercy of the unknown and no serious investor wants that.
I have held and made a commitment to continue holding at least through August at this point, since dCellVax IND has been postponed from March to August, without any of us knowing why. But come August, will there be silence if the IND is not made and we continue to not know why?
Koos won't get anyone but daytraders to invest if the current trend continues of not being able to trust PR and not having updates of both good and bad so that investors can truly follow the development.
Pax et bonum