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To: Pierre S. who wrote (1814)	5/11/1999 6:53:00 AM
From: Mark Bartlett	Respond to of 14101

Pierre, I will try and answer some of your questions: <<But will it pass FDA ?>> Who knows - but it appears that since the FDA is coming up to review the production facilities, it seems reasonable to conclude that there is a good chance that is the case. It would seem reasonable that they would not bother to do this if the other data did not fall into place. <<Where the same studies required, what was there sample size in phase 3,>> We had this discussion about sample size and statistical significance a few weeks ago. At that time some concerns were raised that the sample size could have been bigger - but that fact is, it was large enough to achieve statistical significance. (See reply: Message 8791628 on this thread Further to this point, there have been ongoing phase IV trials for 2+ years. The company used the WOMAC system to evaluate the product - it was developed at the University of Western Ontario and MacMaster - and is the same system used to evaluate Celebrex. Clearly there is a benefit to taking the drug since (according to the company) several hundred users continue to pay for it out of their own pockets, despite government covered alternatives. This includes at least one of the members of this thread. I hope this info helps, MB

To: Pierre S. who wrote (1814)	5/11/1999 7:18:00 AM
From: Jeff Chan	Read Replies (1) \| Respond to of 14101

Hi Pierre... I think Mark pretty well answered most of your questions. Here's some other points. But will it pass FDA ? One can never really know until one sees it in black and white. I am trying to compare it to the only topical NSAID/analgesic I know the FDA has approved which is a Bayer product called Myoflex.I have used it on a few people and it appears to works as well as a placebo. You'd be surprised...many of the especially the older products are only as good as or slightly better than placebo. Diclofenac which is the active non-steroidal anti-inflammatory in Pennsaid has been around for quite some time. The question is not whether diclofenac works but whether the vehicle that DMX has is able to allow transdermal delivery of the drug and whether this process works and is safe. Where the same studies required, what was there sample size in phase3, will Pennsaid be judged the same way ? The same type of studies are required by any company applying for a new drug submission. I can't speak for the FDA, but certainly at the Health Canada website, the Health Protection Branch actually provides a template for all manufacturers of data that is required and how it is to be presented. Hope this helps. Jeff C