Why is Wall Street Ignoring ImmunoGen? [View article]
I don't believe they'll be ignoring IMGN much longer. The Abstact for once a week dosing of T-DM1 shows spectacular results, this should only get better as we see more patients and confirmed Partial Responses in the ASCO presentation which should include nearly six months of additional data.
Add to this the fact that the Clinical Trials database now shows two new Phase II Trials intended to start in July that will greatly expand the potential use of T-DM1 and you can see that DNA with the concurrence of the FDA is looking to rapidly develop this drug.
I've heard it said that a blind man could see this drug is headed for approval, I believe it's not only true, but the FDA themselves might shorten the process as the data's so overwhelming.
I believe all the new trials, as well as perhaps the current trials, could be using Pivotal Material which DNA now has the capability of making, instead of drug supplied by IMGN. The importance of this is DNA cannot gain approval unless the FDA approves its manufacturing capability, this may already have been done.
It's only a matter of time, and I believe this drug will fly through Pivotal Trials once they're started.
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I don't believe they'll be ignoring IMGN much longer. The Abstact for once a week dosing of T-DM1 shows spectacular results, this should only get better as we see more patients and confirmed Partial Responses in the ASCO presentation which should include nearly six months of additional data.
May 16 21:52 pm
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All Comments by skitahoe »Why is Wall Street Ignoring ImmunoGen? [View article]
Add to this the fact that the Clinical Trials database now shows two new Phase II Trials intended to start in July that will greatly expand the potential use of T-DM1 and you can see that DNA with the concurrence of the FDA is looking to rapidly develop this drug.
I've heard it said that a blind man could see this drug is headed for approval, I believe it's not only true, but the FDA themselves might shorten the process as the data's so overwhelming.
I believe all the new trials, as well as perhaps the current trials, could be using Pivotal Material which DNA now has the capability of making, instead of drug supplied by IMGN. The importance of this is DNA cannot gain approval unless the FDA approves its manufacturing capability, this may already have been done.
It's only a matter of time, and I believe this drug will fly through Pivotal Trials once they're started.
Gary