What's to worry about??? As far as I'm concerned, nothing. I'm not holding any shares of this scam. If I were an investor on the other hand I would be worried sick! Just wait till the FDA laughs pmcb out of the building telling them to start all over.
From the latest 10k
There is a risk that the FDA may not accept the data from the two previous trials. In that case, we may be required to conduct a Phase 1 or a Phase 1/2b clinical trial rather than the planned Phase 2b clinical trial, which may result in additional total costs to us and/or delays in the regulatory review process and any future commercialization and marketing, if regulatory approval is obtained. It is not known whether the FDA would be likely to reject the use of such clinical data due to the time that has elapsed since such trials were conducted or because the clinical trial material for our proposed Phase 2b clinical trial is slightly different from that used in the earlier clinical trials as a result of cloning the cells used in the earlier trials and certain modifications and improvements that have been made to the Cell-in-a-Box® technology since the time of the earlier trials.
We intend to conduct clinical trials for certain of our product candidates at sites outside of the U.S., and the U.S. regulatory agencies may not accept data from trials conducted in such locations.
Although the FDA may accept data from clinical trials conducted outside the U.S., acceptance of this data is subject to certain conditions imposed by the regulatory agencies outside of the U.S. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles. The trial population must also adequately represent the population in the country in which the clinical trial is being conducted. The data must be applicable to the U.S. population and medical practice in the U.S. in ways that the FDA deems clinically meaningful. Generally, the patient population for any clinical trials conducted outside of the U.S. must be representative of the population for whom we intend to seek approval in the U.S.
In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will be dependent upon its determination that the trials also complied with all applicable U.S. laws and regulations. There can be no assurance that the FDA will accept data from trials conducted outside of the U.S. If the FDA does not accept the data from any of our clinical trials that we determine to conduct outside the U.S., it would likely result in the need for additional trials that would be costly and time-consuming and delay or permanently halt our development of the product candidate.
Disclosure: I am a involved in and support the SEC whistleblower program, I may be rewarded cash for information that leads to the successful enforcement by the SEC of a federal court or administrative action in $1m+.
