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Re: Rock Kicker post# 45176

Tuesday, 06/02/2015 2:36:56 PM

Tuesday, June 02, 2015 2:36:56 PM

Post# of 45771
So throw DOWN!


Sure, here's one you will recognize. I would be feeling a little better about the SCAM CDEX if they said they were anticipating and able to spend 15 million in 2015 on clinical trials of anything. But they're not. The risk factors for CDEX SCAM read the same year after year. Boiled down it's "if we don't get some more cash from suckers we'll disappear".

Year after year they come and then after they lose it, they go, that's worth rolling on the floor laughing about, especially after they've been shown the evidence. Just ask Robert Stewart, Michael White, Pete Mania, etc. the list is really to long.

http://ih.advfn.com/p.php?pid=nmona&article=66144598

The Company anticipates it will spend in excess of $15,000,000 on IRT-103 (LDN) clinical trials in 2015.

The development of new drugs is a highly risky undertaking which involves a lengthy process, and therefore our drug discovery and development activities may not result in products that are approved by the applicable regulatory authorities on the time schedule we have planned, or at all.

Our drug candidates are in early stages of drug discovery or clinical trials and are prone to the risks of failure inherent in drug development. As of the date of this Form 10-K, both of our current drug candidates, IRT-101 (MENK) and IRT-103 (LDN) have been tested on human beings. We will need to conduct additional clinical trials before we can demonstrate that our drug candidates are safe and effective to the satisfaction of the FDA and other regulatory authorities. Clinical trials are expensive and uncertain processes that can take multiple years to complete. We cannot assure you that our ongoing clinical trials or any future clinical trial of any of our other drug candidates, will be completed on schedule, or at all, or whether our planned clinical trials will start in a timely manner. The commencement of our planned clinical trials could be substantially delayed or prevented by a number of factors, including:

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delays or failures in obtaining sufficient quantities of the API and/or drug product;
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delays or failures in reaching an agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites and with the FDA or other foreign regulatory bodies;
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delays or failures in obtaining Institutional Review Board (“IRB”) or Ethics Committee (“EC”) approvals to conduct a clinical trial at a prospective site;
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the need to successfully complete, on a timely basis, preclinical safety pharmacology studies (for IRT-101 (MENK));
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the limited number of, and competition for, suitable sites to conduct the clinical trials;
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the limited number of, and competition for, suitable patients for enrollment in the clinical trials; and
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delays or failures in obtaining regulatory approval to commence a clinical trial.

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