Anyone own this? Not advising, just my opinion, but the stock looks awfully cheap here $385MM market cap and I think the drug should be approved, or vored in favor of approvel. Just because an "FDA staff expert" asked if another trial should be required, does not make it a fact. PFS was improved and OS did not, mainly due to cross over. I am not sure if they are able to prove that cross-over effect, so if might be a trial design flaw that was patient-friendly and could cause the company harm. It's an interesting speculation here IMO.
that's voted. FYI, before making any decisions it would be good to read the AF article, he points out some potential issues with the patient population/sample, apparently not many from the US, or Europe and that FDA suggested another study back in May. This is a #$%$ shoot as most panel meetings are, but the drug certainly look very similar in efficacy to the closest competitor and better on safety, so to me it should be approved. All IMO, not advice!
As someone on the IV board pointed out, it's a good reminder of the risk associated with small biotech runing phase III trials. The other lesson is that the hurdle is high when current options are available. IMGN needs to keep partnering, they don't have the talent and resources to successfully design and execute a phase III trial.
Tivo works as well as the competition, maybe slightly better, but the pin heads at FDA wanted to show how smart they are and nit picked. If you ask the prominent MD who treats patients and has been involved in the trials for other similar drugs, the nurses and patients, the durg should have been appoved. Fortunately, I went small, but it's still a waste of time and $.