euro union BS
by: Ulose123 12/07/05 05:25 pm
Msg: 35368 of 35371
both drugs are available there, euro union is a non issue you complete half-an-ass. trca issue the suit to limit INSM from spreading word to endos in US. i spoke w/ Ina from TRCA today...they ackwowledge that INSM has a distinct possibility of being granted 'full' approval and they are doing what they need to do to protect their(TRCA) shareholders and Increlex. Basicaly, word on the street is Increlex is not going to sell once INSM approval
lealiljd
by: supacharja 12/07/05 05:34 pm
Msg: 35369 of 35370
Not sure whether you are short INSM or long TRCA, so this response may fall on deaf ears. Europe is a completely different venue and as such, TRCA will need to file a similar suit against INSM in that jurisdiction subsequent to any approval. This would not be a surprising move, one I'm sure INSM anticipates. THE US LAWSUIT HAS NO BEARING ON THE EUROPEAN APPROVAL PROCESS AND REGS. And it should be noted that Euro endo peds are fully aware of the safety differences between Increlex and iPlex, which is the only parallel between the US and Euro processes.
Additionally, you appear to have no knowledge of the orphan regs, which state that orphan can be broken if a subsequent drug is proven clinically superior. The burden is on INSM to prove this and initial indications show solid evidence of superiority on all three fronts.
TRCA is simply posturing....afterall, what other options do they have other than the FDA denying co-orphan? Having said all that, who knows how this thing will ultimately shake out.