Friday, December 19, 2014 12:27:23 PM
Now about the FDA situation - I expect that the final ruling will happen soon, I think by Feb 2015 latest - I cant imagine they will take longer than an year to finalize the rule they proposed. The ruling will cause a significant uptick in the PPS, this is guranteed, almost assured gain. If OTC door is left open, can expect a few cents, if not 1c-2c at least. The next sales numbers should show substantial improvement as there is undeniable sales growth at Boots. The report is only due in March, though. The ruling can come anytime.
After the ruling they can file for clearance (510k, pre-market notification). Note that the bar for Class II 510k is substantially lower than for class III. Only 10-15% of 510k's need any clinical study data at all. However, Biel Corp. have two solid clinical trial results since their last attempts. One on Delayed Onset Muscle Soreness on marathon runners (PI Rasmussen, Aarlborg University Hospital, Denmark), the results of this "double blind, randomized placebo-controlled study covering a 5 days period after completion of a marathon race" showed significant pain reduction and improved running activity for the treated group compared to placebo at p-vales of 0.028 and 0.017 : See the Arlborg study here The second study was for Osteoarthritis, PI, Bagnato, see the osteoarthiritis study here (Messina Italy and Univ. of Louiseville, Kentucky) . p-values for this study are even better < 0.001 to < 0.005 for pain reduction and < 0.02 -< 0.002 for function improvement. Below 0.05 is good, what we have is great especially for 510k. Note that these studies are listed in clinicaltrials.gov. There is also another one (hernia repair) listed with a completion date in Jan 15. So, things are moving, though slower than I would have liked.
The writing is on the wall, folks! This is not a regular pink company - there is sales that you can see and published clinical trial results, from respected academic institutions, Aarhus is among the top 100 in the world. On Boots, in fact, the actipatch back and muscle products have been coming up as most popular under pain relief for sometime now. So in the midst of year-end selling, don't lose sight of where this is going, buy instead, if you can. Place your bets, a move of 10 times (even upto 100 is possible) is on the cards, I have placed mine.
As always, use your judgement, do your DD and put down only what you can lose.
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