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

To: Analog Kid who wrote (782)	1/3/1998 8:42:00 AM
From: Henry Volquardsen	Read Replies (1) \| Respond to of 1115

A.K., I think it was stated on the thread previously that the reason Lidak had not released the placebo comparison previously was at BMY's request. The NDA was a week prior to BMY cancelling the agreement so if there had been such an understanding between the two parties that would explain why the placebo comparison was not released at that time. Now that BMY has backed out of this agreement, if it ever existed, is now void. In that case I agree with others that I would like to see them release this comparison. Ever since the initial phase 3 fiasco I have been wondering about this claim that the origional placebo was active. The thought crossed my mind as well that the healing time from Lidakol could be largely due to a psychosomatic boost. While I still have some concerns I do not believe there is a major psychosomatic factor and I believe the company is being honest about the origional placebo being active. My reason for coming to this conclusion is this, if herpes healing times can be effected by a patients expectations of relieve why then does acyclivir and the other treatments only decrease an outbreak by 1/2 day or so? If psychosomatic factors boost Lidakol why not the other ointments? Lidak needs to come up with some answers. Henry

To: Analog Kid who wrote (782)	1/3/1998 4:01:00 PM
From: John Zwiener	Respond to of 1115

Analog, You mention "no treatment 8 days, lidakol 4, and placebo 5 days". You make an important point, but to clarify..... No treatment-this is the natural history or course of a herpes outbreak Placebo-------This will be the patients that are thought to having an outbreak. But remember around 10% of patients without treatment will regress anyway. This will skew the results from 8-10 days to 7-9 days. The placebo effect is probably minor but could also contribute to a decrease. Finally, when patients present to the clinic to get treated, they are may or may not really have a herpes outbreak.. The researcher decides if what the patient complains of; is it herpes? Since it appears that this latest phase 3 trial tried to catch the outbreaks earlier (4.1 days versus 5 days for the previous trials), it's possible that some of the patients were classified as an episode of herpes, when they may not have had one----this would also skew the placebo results downward more than the treated group. Treated group--- we got the number and it is impressive, but as you can tell from what can happen with the placebo group, it's hard to make a comparison without the placebo numbers. Luis made a good observation on the Yahoo pages that Lidak did say that the original phase 3 studies were not significant. So one would expect lidak to come clean this second time around also. But still the placebo numbers need to come out at this point because this is going to keep building up. Perhaps if BMY had not have backed out they could keep to their policy, but maybe a reaccessment is in order. Think of the free advertising lidak would get ahead of time. CNBC reported that BMY back out, wouldn't they want to report that BMY made a dubious decision (if the placebo numbers are good?), ////Also might make getting a good deal with a large pharmaceutical company easier, more competition.........holding.