Spud, I know how you feel about FDA. That hope has been all that's sustained many investors. That, and the hope that we might be able to kick those bums out of management.
Way back when, I posted:
"Saved, from Canada's saviors, was Dimethaid - by the location of its present and future production facilities in Varennes. No one else could have done it. Without the influence of the Bloc, we would all probably have died, waiting for approval from HC. I wonder if we'll have to build production facilities in the States?"
As Captainklutz pointed out, however, HC got the last laugh by giving Pennsaid a "non-approval approval"
"That 3 month approval is another major problem I meant to point out. It's actually right in the indications section of the product monograph. It's approved for a 3 month period of use whether continuous or in the aggregate.
I've never seen Health Canada force this type of restriction on a drug that is intended for chronic use. It's basically a non-approval approval. Approved for sampling purposes only. Kind of mind boggling that people at Health Canada get paid for pulling this kind of nonsense. Force a company to do a long term phase IV trial before approval but then reject the data because it isn't blinded. Only in Canada.
In any event, the limitation is a key reason the formularies won't provide coverage. One of their big concerns in addition to price, is inappropriate usage, off-label for instance. Any use of Pennsaid for more than 3 months is off-label. That's the perfect excuse for the formularies: it's not supposed to be used for more than 3 months so why should coverage extend beyond that. In the best case scenario they might cover it for 3 months. Whether that would provide meaningful coverage for patients who would be forced to pay for it out of pocket after 3 months is debatable."
stockhouse.ca
The question is: has FDA imposed the same limitations on Pennsaid? Is that what caused the non-appearance of "good news" two Augusts ago? A few of us speculated at that time (using exactly the same phrase: "non-approval approval") that FDA did approve, but that the approval was so limited that it didn't meet the needs of Dimethaid or JnJ. So RK sent it back.
But, as Klutz pointed out with HC, that presumably would have required more trials, ergo more cash. Management's estrangement from The Street, and cost-effective financing means that ain't gonna happen. Which means no FDA approval.
Well, you never know. FDA approval would be a good thing, regardless of how we feel about the clowns managing the company.
Maybe it will happen. My guess is that whatever approval Dimethaid settles for (if any, which I doubt) will be a "non-approval approval" - maybe even worse than HC's.
Regards,
Jim |
