To: russet who wrote (12144 ) 2/21/2003 7:38:30 AM From: axial Read Replies (2) | Respond to of 14101 "I see a drug that will easily be duplicated as soon as DMSO based topical lotions are approved by the FDA (Pennsaid)..." That statement is possible, but is by no means a given. It depends on a number of factors: 1 - Determining bioequivalence is problematical. As di7026 pointed out, the makers of the patent, if they've done their job well, will not have divulged certain proprietary information in the patent application. 2 - Your statement is written as if duplication will begin immediately and automatically. Not so. There is a trigger point for creation of a generic equivalent - the established market. Estimates vary, but some put the trigger point for creation of a generic at $1 billion US. 3 - "there are many variations of the mixture that will surely work as well and are not protected by the patent,... " If they claim therapuetic benefit, and are not bioequivalent, then they will need to be approved by the FDA."...variations...that will surely work as well..." - a hypothetical, unproven. Your projection is based on an unproven (and potentially erroneous) conclusion, that lacks clinical data, or even evidence from widely used predecessors. 4 - DMX has claimed that it "has a strategy" for patent extension. Leaving that aside for the moment, let's look at the history of other drugs that have sought patent extensions: many have achieved extended success. The familiar tactic of "improving" the already-patented product is also available, and it has a long history of success. Regardless of DMX's particular strategy, it's clear that there are a number of methods by which DMX could extend its Pennsaid monopoly. If DMX succeeeds at any of them, then the creation of "look-alikes" becomes a risky proposition, for fear of litigation. 1 - "second drug that is quickly being made redundant (WF10) by dozens of drugs that have known mode of actions on point immune sources with few side effects." - Unsubstantiated projection based on unproven premise. Evidence so far is that WF10, too, has "few side effects". - "quickly being made redundant"? Please demonstrate not dozens , but just one dozen drugs that have successfully passed through Phase 3, and gone to market for the same indications as WF10, thus rendering it "redundant". Please demonstrate the clinical success of not one dozen, but just half a dozen of such drugs. Please demonstrate how you know that these drugs are superior to WF10, and will thus make it "redundant". Please explain why the objective reader should not regard these comments as hyperbolic, prejudicial, and unsubstantiated.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Russett, perhaps could you clarify these points. Regards, Jim