"The most common reasons for Phase III study failures or failure to receive approval to sell a drug, other than the drug not working, are: 1.Phase III study not reviewed by FDA and not acceptable to FDA: Our Phase III study was reviewed in detail and we made changes based on FDA’s comments prior to commencement of the Phase III trial. 2.Study too small:Our study will enroll 800 patients, a very large number. 3.Clinical endpoint not relevant:We follow overall survival of the patients, the gold standard. The clinical endpoint cannot be more relevant. 4.Change in treatment protocol between Phase II and Phase III without additional studies: We have made no changes. Therefore we expect the Phase II results to be representative of the results one can expect in the Phase III trial. 5.Insufficient attention to manufacturing issues: We have validated our manufacturing process and built a dedicated manufacturing facility for Multikine.
Why do we believe that Multikine will get to market? •We avoided the common problems listed on the page before. •All clinical indicators support the finding of increased survival in Phase II. •10% increase in overall survival needed for Phase III success, and is much smaller than the 33% increase seen in Phase II. •No toxicity issues. •No safety issues. •Clear unmet medical need. •FDA granted Multikine Orphan Drug status in the USA."
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