Wednesday, February 10, 2016 10:51:32 AM
"The Company estimates that the cash in hand is sufficient to enable us to perform initial human clinical trials of at least one of our drug candidates, as well as to advance at least one more drug candidate drug candidate towards initial human clinical trials."
"In the HerpeCide™ program, the Company is currently developing drugs against four different topical indications, namely: (a) skin cream/lotion for the topical treatment of "cold sores" (typically caused by HSV-1); (b) eye drops/gel for the treatment of ocular herpes keratitis (mostly caused by HSV-1, sometimes by HSV-2 primarily in neonates); (c) skin cream/lotion for the treatment of "genital lesions" caused by herpesvirus (typically HSV-2); and (d) skin cream/lotion for the treatment of shingles (caused by HHV-3 also known as VZV i.e the chickenpox virus)."
From the 10-Q:
"We anticipate that we have sufficient funding to take at least one of our drug candidates through initial Phase I and Phase II human clinical trials. At present, we believe that we may also have sufficient additional funding in hand to take at least one more drug candidate into an IND application stage."
"The Company is evaluating the possibility of performing Phase I and Phase II human clinical studies internationally. It is widely believed that Phase I studies can be performed in Australia more quickly than in the USA due to differences in regulatory procedures and guidelines."
"With our current funds we believe that we have sufficient funding available to perform Toxicology Package studies, and additional animal efficacy studies, to move at least one of our drug candidates into an Investigational New Drug Application (“IND”) with the US FDA or a similar application with an international regulatory agency, and to conduct Phase I and Phase IIa human clinical trials of at least one of our drug candidates."
"5. If and when we initiate human clinical trials for any one of the HerpeCide indications, we anticipate approximately $1 million in total costs for the Phase I clinical trials, and approximately $2 million for the Phase IIa (human efficacy study) clinical trials.
6. If and when we initiate human clinical trials for Injectable FluCide, we anticipate approximately $2 million in total costs for the Phase I clinical trials, and approximately $4 million for the Phase IIa (virus challenge human efficacy study) clinical trials.
We believe that we have sufficient funding available to accomplish the steps 1 through 6 listed above with our current available cash."
"In addition, in a subsequent year, if our anti-herpesvirus Phase I and Phase IIa are successful, we anticipate approximately $5 million for anti-herpesvirus Phase IIb (human efficacy study in a larger group of patients) human clinical trials. Further, in a subsequent year, if Phase I and Phase IIa of our Injectable FluCide drug candidate are successful, we anticipate approximately $7~8 million for Phase IIb human clinical trials."
Above posted just for the record and further consideration as to its consistency and its actual meaning.
It's morally wrong to allow a sucker to keep his money.......Cuthbert J. Twillie
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