ImmunoGen Inc (IMGN)

[skitahoe]

I believe that IMGN's movement since quarterly results were issued is purely based on anticipation that discussions with the FDA on a path to approval for IMGN853 will have a positive conclusion. Clearly the best course would be an agreement to submit a BLA this year based on the Phase 3 for the patient group that received the greatest benefit in the trial. As I see it, the worst case would require an additional trial that added more patients to the group receiving the greatest benefit, which would delay the approval by a couple years. Of course it's also possible that the Phase 2 Trials using drug combinations could result in an approval out of Phase 2.

Some of the combination trial data will be presented at ASCO. The Phase 3 Trial I believe will be discussed a few months later at ESMO. By the time of ESMO I think discussions with the FDA should have concluded, and the company can state what will come next. At the quarterly the company indicated that if discussions with the FDA go well, they'll submit a BLA for IMGN853 approval before the end of this year. If this comes to pass, I believe we'll see a ROW partnership and approval by the end of the first half of next year. I believe that highs not seen in a few years will be reached by the new year if a BLA is being filed, somewhere in the $20's is very possible.

Gary