RT $1.25, down $ 0.03.
Naar aanleiding van een vraag van een van de posters op het Yahoo-forum, heeft een van de “longs” de moeite genomen om, zonder al te technisch te worden, uit te leggen waarom een FORMEEL FDA approval op de 12de December hoogst waarschijnlijk is.
Omdat, indien ze inderdaad de FDA approval krijgen op de 12de, de prijs nu nog lekker laag is, dacht ik dat deze ‘post’ tussen alle andere ‘clutter’ er even uitgelicht moest worden.
<<by: kabbamonte (55/M/Cripple Creek, CO on good) 12/02/05 03:42 am Msg: 34695 of 34699
We have discussed this a zillion times already, you can set your counter back to 30,000 or so and work forward.
Basically, it is all about orphan status for the US. The implication is that if INSM gets approval with orphan status, most likely on a "shared" basis with TRCA, then that would be because it was considered to be a "superior drug", although it may or may not be considered a "different drug" from TRCA. The most popular opinion here is that doctors would choose to prescribe the "superior drug" (mainly because of once a day injections vs two for TRCA, and fewer hypoglycemic reactions).
Beyond that, if both drugs are covered by insurance, and economics of price are not a consideration for either one, it makes sense that most of the market share would come to INSM.
TRCA has a jump n marketing by a few months, and on one hand they are going ahead like INSM don't matter. Also discussed at great length is a potential dark cloud over pending litigation between TRCA and INSM, should INSM get the good news. However, with FDA backup on their decision, many here feel that TRCA's litigation would be tantamount to harrassment and not amount to much. However, the last thing INSM needs is to have money tied up with such matters. TRCA just got $75 million financing arrangement which gives them leeway to pursue litigations.
Many posts here can get quite more biological and technical, but you may tune in to the archive on recent webcast by INSM, which goes into the IPLEX vs INCRELEX comparisons.
and, just in case you don't know, INSM has already received an "approvable" letter from FDA and INSM made a quick supplemental submittal of some extra data requested from them. We assume that was info that would help them with "orphan" decision.
So, basically, it seems very likely that IPLEX will be "approved." However, without orphan status attached, that means IPLEX cannot be marketed in the US for 7 more years (not sure if that means Canada and Mexico, too), but may be marketed overseas subject to whatever regulatory hurdles over there.
This would be a mixed blessing sort of news, which would also put INSM in much more economic hardship and certainly draw out the process beyond the patience of many.
There are many posts on the "to the moon" and "to the dungeon" prospects of the price. I think we are all in discussion fatigue and it's all up to FDA right now, no matter who says what at this point.
I think Insmed's pipeline has the "to the moon" potential. Orphan status for this application opens the door to very lucrative possibilities. >>
Dacht dat de potentieel geinteresseerden hiermee gebaat zouden zijn!
Geluk, F.