Zebra,
I have to say that your posts add great value to this forum.
Two points for discussion:
1. I recall from the CC that the second factory was inspected by
the European (or UK?) Medicine Control Authority (MCA) on 12/5/97
and that approval? was expected in 30 days (or early January?).
If history repeats itself (as is usually the case IMHO), they
will have to fix some things before getting a perfect report
card. (Peering into my Crystal Ball, there is a vision that
maybe this is the "inside information" that caused the recent
flame here--such a thing would be known to many people at Vivus,
Paco, in Europe, and maybe at the FDA too.) Does anyone have
any information on the status of the MCA inspection report?
Also, will MCA approval of the second plant allow shipments to
non-UK countries such as Sweden where approval is expected next?
2. The MUSE applicator device could, theoretically, be used with future combination therapies that might not even include alprostadil:
e.g. phosphodiesterase drugs, alpha-blockers, etc. So the future revenue stream could be affected greatly by any adverse
reports re the MUSE device such as urethral pain, inflammation,
or even infection. To all the prescribing M.D.s: how painful
is the application process? How many patients are averse to trying
it? And, how many adverse reactions are found to the applicator?
David |
