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Biotech / Medical : Lidak Pharm. [LDAKA] -- Ignore unavailable to you. Want to Upgrade?

To: telebob who wrote (786)	1/4/1998 2:04:00 AM
From: luis a. garcia	Read Replies (2) \| Respond to of 1115

This is one of these knit picky gourmet things that really confuses me too.. telebob... The null hypothesis the Medicine in this case is better than the placebo. the P numbers come in inside the 95% confidence which is as required to prove the null hypothesis... then all this hype about the placebo numbers and lack of numbers... Now I am not saying it is not justified... I just simply don't quite understand the concern. Regardless of when the placebo outbreaks were concluded in time The statistics still showed significance. Now look at it a different way in order to prove 95% confidence what is the minimum time between cures in each case??? This poses a rather interesting statistic problem... Best we can do is say if 8 days is baseline for no treatement i.e. placebo group then must be around 8 days and Lidakol treated group is less than that... but How much less?? is less?? I guess that is the rub.. However everyone gets better regardless...in time. Then the null hypothesis needs to be time related in order to make any sense... and if it is then we know the P numbers show the difference IS STATISTICALLY SIGNIFICANT...so guys take two aspirin and call me in the morning.... Don't forget the BIG thing is the secondary end points which Jeff Weinress alluded to ...LIDAKOL if used when the first tingle is felt can SPARE some people the whole ORDEAL..... that is one to celebrate...FDA should fastrack this medicine....ASAP. CHeezzzz luis

To: telebob who wrote (786)	1/5/1998 5:30:00 AM
From: Henry Niman	Respond to of 1115

telebob, Although a p value of less than 0.05 is statistically significant, the FDA frequently likes p values of less than 0.01. The p value of 0.035 is definitely in the "iffy" category. With 743 patients, the difference between Lidakol and placebo is very small.

To: telebob who wrote (786)	1/5/1998 6:12:00 AM
From: Henry Niman	Read Replies (1) \| Respond to of 1115

Here's what the San Diego Union Tribune had to say: Lidak loses partner in marketing of new drug Thomas Kupper STAFF WRITER 01-Jan-1998 Thursday Lidak Pharmaceuticals said yesterday that marketing partner Bristol-Myers Squibb had backed out of a deal to market Lidak's cream for oral herpes. The San Diego company's drug, Lidakol, had stumbled in clinical trials a year ago, but Lidak completed trials that appeared to put the product back on track. Just a week ago, Lidak submitted an application to the Food and Drug Administration for approval of the product. "We have no specific explanation for this cancellation, except that it does not relate to the therapeutic potential of Lidakol," said Lidak chief executive David H. Katz. The Lidak deal is the third such collaboration to unravel for San Diego biotechs in recent weeks, as pharmaceutical companies review their research portfolios for the new year. Agouron Pharmaceuticals and Alliance Pharmaceutical saw their stocks tumble after losing such partnerships for major products. But those products appeared to be farther from market than Lidakol. Lidak shares closed unchanged yesterday at $2.37 1/2 before the announcement. In the original Lidakol testing, the cream failed to show clearly better results than the placebo, another compound that eased oral herpes symptoms. So the company switched to a true placebo that did not ease the symptoms. Lidak said the new results showed that outbreaks of oral herpes, a common condition characterized by facial blisters and accompanying itching and burning, cleared up on average in 4.1 days. Without treatment, outbreaks typically lasted eight to 10 days.