Mark,
I heard that one question from you. I'm sure it was you because just a couple of days ago I heard you ask exactly the same quesion. Am I right?
A couple of points about that interview on ROBTV.
She really can't comment publicly on FDA; but, she did say (I forget the exact wording) that she was comfortable with both North American submissions.
Last year I was hanging on every word too much and this year I'm more interested in the fact that we're expanding the plant at this time, about Acqua, about the WF10 phase III, about product launch, european timing - in other words real events versus the words.
The words I did like though were related to market sizes. For the first time I've heard what I consider a truer estimate of the market now sized at $12 billion US.
And in conjunction with that she mentioned 10% where the previous public statements were 5%.
Having stated in one interview the $12 billion and 10% any new potential investor will come away saying, "OK, so they're targeting $1.2 billion US in sales."
The second point is plant inspection. Whether or not there had been a previous FDA inspection, the expanded facilities would need to be inspected again and it would be the expanded plan that would be submitted for final approval.
I saw no denial that they had been up. Only a proper statement that Dimethaid was hoping the inspection was in the near future (after the expansion is complete).
I'm not particularly focused on this. FDA brings a triple digit stock price with it and as I've said so often, I have 100% confidence that Pennsaid will eventually be approved everywhere it applies.
I like the fact we're expanding while taking little cash from placements in.
One last point right now. We will be doing larger studies down the road just as Celbrex and Vioxx did to improve our labelling and definition as a medicine.
I like our chances when that's us up there a couple of years from now getting premier acknowledgment that Pennsaid is the safest NSAID with the full power of NSAID for over half of all of the market.
That's the game plan in my opinion and after that, we're talking COX2 type numbers and share price in the 200 plus, plus range.
Get some rest Rebecca. This is a gruelling pace.
Wolf
PS - fungal product clinical trials may start this year. |