"Since we are seeking approval for Zerenex under a SPA, based on protocol designs negotiated with the FDA, we may be subject to enhanced scrutiny. Regardless of the success of our Phase 3 clinical trial, a SPA does not guarantee approval. The FDA may raise issues of safety, study conduct, bias, deviation from the protocol, statistical power, patient completion rates, changes in scientific or medical parameters or internal inconsistencies in the data prior to making its final decision. The FDA may also seek the guidance of an outside advisory committee prior to making its final decision. Additionally, the regulatory approval of new therapies could invalidate our SPA, or require us to conduct additional, expensive clinical trials to obtain regulatory approval."
The CLSN board also pumped a "sure thing". When the consensus is a "sure thing", take the opposite bet. There ain't no sure thing and do you really think that all the imbeciles flocking here for the pumped "sure thing" will be allowed to make easy money?
Might want to rethink that, just a bit. Still hasn't settled into a good trading range, but support seems to be at 6.5 and R at 7.5 so it could bounce around like that for the next year as they get approval. Make some of your money back playing the range. Happy Trading!
"There can be no assurance that safety and/or efficacy concerns from the prior data were not overlooked or misinterpreted, which in subsequent, larger studies might appear and prevent approval of such drug candidate. In addition, top-line results reported on completed clinical trials are based on a preliminary analysis of then available data (both safety and efficacy) and there is the risk that such findings and conclusions could change following a more comprehensive review of the data by us or a regulatory authority."
"Safety signals detected during clinical studies and pre-clinical animal studies, such as the gastrointestinal bleeding and liver toxicities that have been seen in some high-dose, ferric citrate canine studies, may require us to perform additional safety studies or analyses, which could delay the development of the drug or lead to a decision to discontinue development of the drug."
"The FDA has not requested us to conduct a two-year carcinogenicity study in animals, there is no assurance that prior to, at the time of, or subsequent to the filing of an NDA that the FDA or some other regulatory authority will not ask us to conduct such a study."