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ik zie aanklacht van TRCA tegen INSM idd als een teken van sterkte van INSM
en grote kans dan op FDA goedkeuring in dec 12
yahoo posting: zo denk ik de er ook over
Thoughts on INSM
by: jmaj742 (38/M)
Long-Term Sentiment: Strong Buy 12/07/05 02:54 pm
Msg: 35312 of 35313
As a long time holder, I'm enjoying the anticipation for our upcoming FDA decision. Years back when I originally bought, TRCA was not even around. How things change in short order. My take on the recent lawsuit is that it is a positive take on INSM. TRCA management must believe that INSM will get approval and orphan status, otherwise their is no need for the lawsuit. I question the timing, in that if INSM does not get approval w/ orphan, the suit is for not!--TRCA has market exclusivity and INSM has no marketing or sales in the US to compete with TRCA if INSM is denied orphan. From all the conference information I've referenced, INSM has posted only documented comparisons of Iplex w/ increlex that came from public information. Most of the IPLEX comparison data I have seen has been that compared to Pharmacia data. Most the negative data posted on Increlex was in the CP-Citizens Petition, but all the information was documented information from TRCA. I don't think TRCA wants a head to head trial, because it would only go to prove what we know, IPLEX is safer. The only thing a head to head trial would help is drain funds from INSM they could be using on further indications. At this point, I think TRCA is down to draining INSM of precious funds as a last ditch effort. On INSM getting approval, I think we've gone over many possibilities the FDA has for approving with orphan--Different drug, greater safety, easier dosing regimen ect. Things are going INSM way at this point, and the FDA announcement is coming soon. I think the TRCA lawsuit only confirms what I believe should and will happen--INSM will be approved for SS and receive orphan as different drug, or co-orphan as same drug with better safety profile. Hoping for the best!