Hi Russett,
The world doesn't work that way much to our detriment.
Actions are as often ego gratification or random as they
are goal driven or accepted process.
Thus the EU's adherence to the MRA for drugs and Health
Canada's phase 3 - phase 4 - phase 3 - black hole shuffle.
The best example may be the Acqua deal. The verbage
of the agreement (and holding period) versus the actual
mechanics (as uncovered, documented, and forecast by this
board).
The big players will be here all too soon. Just as soon
as much of the risk is gone. Dimethaid did not enter a
relationship giving one of them process control. There
are hundreds of companies just like us and when one gets
interesting - it gets bought. High risk at $5 doesn't
sell in boardrooms the way strong prospects at $15 do.
Large investors and drug majors hate to fail even when
we're talking the peanuts DMX is. Risk weighted it doesn't
cut it.
The marketing in the UK is still in bleeding edge stage.
That is, early adaptors have tried it and have had some
time to judge results. Their experience will be shared
through the strong peer relationships. This will be much
more effective in europe than uppity patients suggesting
their own ideas. Advertising is illegal in the UK. Neither
of those situations exist in North America.
The wedge should grow steadily for reasons understood here
(it works and works well) largely due to the predicted high
refill rate. As doctors see results from their own
early adaptive patients they will suggest it to less
adaptive patients more confidently.
In the US it will be TV day one. J&J is interested in
Pennsaid as a means to the enourmous NSAID market with
a nicely differentiated product. 80 million in sales is
not on their minds (1%). Bluntly, that's stupid.
In assessing the risk to successful FDA approval I would
estimate over 95% is getting approved to be inspected. I
think passing the inspection for dummies might be a third
visit to re-inspect, and getting the approvable to approved
is finally a matter of the FDA decisions on labelling,
marketing, etc - like the terms or lump them.
I agree with you that I expected more from Europe overall.
Still we've learned a lot that should provide experience
in future biotech investments (at least for me).
We must remember the road we've come down to understand
investor sentiment. Lots of delays. Little communication
during periods and unmet expectations set by themselves.
Not to mention some Bay street feelings.
I see 2 possible scenarios:
1. Pass inspection. Get approvable letter. Sign with
J&J. Finalize labelling, marketing, advertising words,
etc. Launch at some future date.
2. Correct errors and pass reinspection. Get approvable
letter. Sign with J&J. Finalize labelling, marketing,
advertising words, etc. Launch at some future date.
According to my reading inspection is the last 'test'.
The following quote posted earlier suggests to me there
is a decent chance of passing the first time - but I'm
satisfied with either scenario.
While passing the FDA inspection is not assured, the Varennes facility did
pass an independent EU inspection by an inspector from the UK Medicines
Control Agency before approval was received last year in the UK. Ms. Keeler
hired independent consultants to audit the plant ahead of the formal
inspection and McNeil did a prior inspection as well. An August 16 press
release stated the Company was continuing "to recruit technical staff to
meet its quality requirements in support of a pre-approval inspection by the
U.S. Food and Drug Administration" which may indicate the company was
receiving council directly from the FDA on how to ready the plant for
inspection.
Wolf |
