Michael, thanks for reposting the 1996 Phase III results. Nevertheless, the only scientific conclusion one can draw from this study is that Lidak is no better than placebo within this study. The study mentions a healing time of 4-5 days "compared to the 8.9 days these patients normally have." This is an intriguing observation, but it is sloppy science to compare these 2 numbers. Notice how there is no p value assigned to the "Lidakol" time of 4-5 days when compared with the "historic healing time of 8.9 days." There is no p value because you cannot compare the 2 sets of data!! The only way to directly compare Lidakol with untreated lesions is to have both of these groups enrolled within the study from the beginning.
Likewise, the pain resolution of 2-4 days with Lidakol is compared with "historic" data of 6 days "as described in the literature."
Making these comparisons is very sloppy science and unbecoming of a biotech company trying to gain credence in the scientific community. The only scientific comparisons one can make are the actual study groups involved. In the 1996 phase 3 trial, the only 2 groups were Lidakol and placebo, and these were equal. To suggest that Lidakol and placebo are "active" because they are better than "historic" data is pure speculation, scientifically speaking.
Lidak has refused to release details regarding their most recent phase 3 trial , as we all know, and instead has once again compared Lidakol to "historical data." Lidak has a history of taking any bit of small good news and trumpeting it with press releases. Why won't they let us know these "positive" results????
We must also analyze the Bristol Myers decision carefully. They have made billions of dollars bringing hundreds of drugs to market for decades. They know what will work and what won't. It costs them almost nothing to continue their longstanding agreement with Lidakol. Yet they have walked out the door. They had an almost exclusive licensing agreement with a drug touted to be a billion dollar drug, and by walking out are allowing all competitors to have a shot at Lidakol. Why??? To me, Britol Myers was a "smart" investor and an "inside" investor. When they walked, I took my lumps and huge loss and sold.
I don't think Lidak is committing fraud. I don't think they have ever lied. But I think they are very misleading. I hope for everybody else's sake on this thread that I am wrong. Lidakol could very well have some benefits, but they are probably not blockbuster results. Still, Lidakol is so benign, the FDA just may let it pass. It just bothers me that Bristol Myers is walking away, at no cost to them, and opening up this product to all its competitors.
p.s. To Henry: Regarding Dr. Katz's recent "investment" in Lidak. The fine print of the annnouncement notes that a portion of the funds needed to exercise the warrants came from selling of Lidak stock from Dr. Katz's holdings. . In other words, he sold Lidak shares to buy Lidak shares. It looks like a sizeable portion still came from his own pocket, though.
biz.yahoo.com |
