Hi, Wayne -
"Second, what the hell is "labeling issues" that keep getting kicked around?"
Wayne, if I wrote a post on this, it would be pages long. I can't hope to easily explain the issues that are being dealt with.
What follows is an oversimplification. I'm just trying to make something clear and understandable, not scientifically accurate.
Basically, it comes down to problems of measurement, problems of science, problems of semantics.
"What are we measuring?"
"Has a trial proved what you want to say in your labelling?"
At our level, it seems good enough to say, "This stuff works! It's great!"
At the FDA level, at the research level, they can't even figure out exactly how to measure pain. They can't even figure out how to measure relief. Yes, they have ways - but as you will see by the following links, by their own words - it's a real problem to them: not only deciding what they're really measuring, not only how to measure it - but how to accurately - scientifically - describe not only the pain, but the nature of the relief.
Of course, this whole problem of measurement, of semantics, of statistics, and scientific truth goes right to the heart of - you guessed it - labelling, and marketing: what you can say.
So, if any investor wants to understand the nature of this dilemma, and why Pennsaid gives the regulatory agencies such difficulty, then go here:
fda.gov
...and in the search box, upper left, type in "Dimethaid" (without the quote marks)...
...and read the links that come up. Print them out. Highlight the problems the speakers mention. Study them. Really read what they're saying - because almost all of the problems they speak of have relevance to Pennsaid.
There is no easier way to understand what's at the heart of Pennsaid question, for the regulatory agencies.
Indeed, Wayne, many of the questions to which they refer also relate to the inability of your physician to comprehend the benefit of Pennsaid. Science and semantics have not yet given these people the framework in which they can properly evaluate and state Pennsaid's benefit.
Read those links: that's what they say. Though they don't state that about Pennsaid, specifically, they do state it, as a general case.
By their own words, the measurement of pain, the description of pain, is inadequate. If you can't measure it, and you can't describe it - how are you going to label the relief?
Regards,
Jim
(Edit: This is only for those who really want to understand the issues. A quick scan won't do it. You have to read it, try to understand it, and think about it: you have to study it.) |
