Jeff,
Perhaps I can address some of your thoughts.
<< Two of these studies are in a somewhat obscure journal called "Pharmaceutical Research" as opposed to, say something like the "New England Journal of Medicine".>>
Years ago, DMSO the carrier agent in Pennsaid, got a rather rough ride from one of the allegedly more credible journals, despite the fact that they did not appear to really know much about the agent. A rather unfortunate situation, but one that put DMSO on the back burner for many years following. The mere mention of DMSO and people began walking the other way.
Re: Trials
In some people, DMSO can leave a slight taste in one's mouth, so doing a double blind placebo controlled study was made much more difficult - some would know immediately who was getting Pennsaid and the placebo - hence the rather lengthy phase IV study involving (to date) 3000 + subjects.
As far as if it works or not - people that continue to take Pennsaid have to pay for the meds (60 bucks) out of their own pockets. I doubt they would do so if the stuff did not work. In addition, I have spoken to people that use it and they indicate it is very effective.
As far as super large studies go, DMX is not J&J .... they chose to finance the trials themselves and have done so without spending huge sums of money. That puts them is a much stronger bargaining position .... takes more time, but they do not have to sell their souls in the J/V process. IMO that is why J/V negotiations are taking a while - they are in a strong bargaining position and intend in taking advantage of it.
<<Maybe I'm way off base here, however, I've been in the
pharmaceutical field for over 15 years. In my position, I have
responsibility for reviewing data for drugs that companies wish us
to use. I have not seen the same breadth of data from DMX.>>
Appreciate your comments. I do not believe it is a data issue - just an over-burdened Canadian approval system (budget 30 million -peanuts). I would have to check the submission dates, but believe the data was submitted to HPB two+ years ago and to FDA about 1 year 8 months (or thereabouts). Pennsaid passed the preliminary FDA drug screening (where I have been told about 70% fail) so that is positive - certainly no guarantee.
Best to you,
MB |
