To: bdalarge who wrote (8098 ) 11/23/2001 1:15:04 PM From: Joe Krupa Read Replies (2) | Respond to of 14101 Dave,"As much as I would like to agree with you, I think there is one problem with your thinking. If we had an approvable letter for Pennsaid then I believe that would be considered material and Dimethaid would be forced to release an NR." You would think so. Though after reading further about what an approvable letter actually means I'm not sure. There are conditions that have to be met right from the initial NDA filing all the way up to the time final approval is granted. Until the very final condition is met, even if that means the plant front door needs to be painted pink, then we are not going to receive approval. Yes, every step of the way, and every condition we satisfy, gets us closer to approval. But, there is no ability to receive approval if even the most minor and trivial condition is not met. In that sense, there is no hierarchy of approval importance - every issue or condition met is just as important as the other. Painting the door pink is ultimately just as important toward getting approved, as is proving the drug does not kill people. What am I trying to say? Basically, that until final approval is received, there really is no material news, since there are still issues to be resolved or conditions to be met. In other words, passing through the pharmacology and statistical departments means squat if they don't pass the plant inspection. An "approvable letter" really only says that certain conditions, out of many" have been met to date. Perhaps my logic is flawed, and I would be willing to consider all other opinions. This just happens to be my 'pinion. I admit that this argument I have presented, approaches "material event" from the perspective of an event that significantly changes the reality of a business, not of the TSE definition of "material event" which is purely based on the capacity of an event to move the stock price. That in itself may discredit everything I have just said."If I am wrong about that then the other side of it is that there is no way in hell that kind of information would not have been leaked. With that type of leak we would see much greater volume and the price inching forward not backwards." Heck, the plant inspection was not only leaked, Rebecca came right out and put it in print. A few days later, it has not really done a heck of a lot for the stock price or volume - we are drifting back from whence we came! My point is that, if actually announcing an FDA development such as a plant inspection, in print, can't really move the price and volume, why would a rumour or leak? The reality is that many people barely believe words from Rebecca's own mouth, let alone through a third party leak. joe