Our therapeutic compounds may not be able to be manufactured profitably on a large enough scale to support commercialization.
To date, prior to our curtailment of operations, our therapeutic compounds have only been manufactured at a scale which is adequate to supply our research activities and early-stage clinical trials. There can be no assurance that the procedures currently used to manufacture our therapeutic compounds will work at a scale which is adequate for commercial needs. In the event our therapeutic compounds cannot be manufactured in sufficient quantities for commercialization, our future prospects could be significantly impacted and our financial prospects would be materially harmed.
This has been a recurring RISK FACTOR in all of the NSPX filings. It also, some believe, may have been a reason why NSPX has not progressed into a PH III trial and /or why further development of the drug has been halted. Now with the pending issuance of the PHYTON production patent for thagsigargin this may all change and interest in MIPSAGARGIN may increase.
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