I have it on reliable authority that the FDA will be giving thumbs up, an enthusiastic thumbs up to TDMI. The news may break this week, or they may wait until next week, but they will meet the PDUFA date. I have it on from as reliable a source as you could ever want that the only discussion the past few weeks has been around the labeling on the box. Don't know anyone at Immunogen, but the top people at Genentech and Roche are convinced that the drug works better than anything else out there not only as adjuvant in cases where standard of care has hit the wall but as a first line single agent therapy. The significance of this cannot be overestimated because it means that millions of newly diagnosed women will not only live longer but have quality of life unattainable with existing treatments. To what extent this will be indicated in the intitial label insert is the subject of discussion, but there is no question where it is going and how it will be ultimately used. The approval announcement could come this week, perhaps not until next. I am sure the FDA will meet the PDUFA date. I will tell you something else and this is just my opinion but I think the stock will move big time. Fewer than 1/100 drugs that start trials are approved. IMGN has never had an approval, this will be not only their first, but a huge validation of TAP going forward. The float is small and the short interest is really high- more than 10X the average daily trading volume. As the drug gets approved and the medical world and the women's health advocates begin to understand what a huge deal this is, there will be a short squeeze, and it could be a bona fide doozy.
IMGN will be a bigger blockbuster than anyone thinks. Their approach to the linker seems smarter than what SGEN is doing, at least from what I've read and it appears IMGN will have a greater potential at sucess than SGEN despite their more successful rate of partnerships.
read the interview of Dr Lambert that was posted on investor village. it's really quite interesting.