What I don't get | IMGN Message Board Posts

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Msg  49457 of 49779  at  5/15/2019 8:37:25 PM  by

GaryM


 In response to msg 49456 by  jv08201
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Re: What I don't get

I don't believe the FDA thinks IMGN would walk away, but I do believe that if IMGN had partnered the drug with a BP, they'd probably been able to get it approved. In spite of all the FDA retorick, they still are biased toward BP who pay most of their bills. No way of proving what I'm saying, but should IMGN partner the drug, I believe the new Phase 3 will be less rigorous than what IMGN will need to do if they go it alone.

It seems to me that IMGN has said all along that it wanted a ROW partner for the drug. If they established that partnership today, I suspect that approval could be achieved by the partner in Europe and elsewhere on the strength of the data to date.

I had really hoped that our FDA had become more dynamic, and perhaps in some ways they have, but not in this case, and I still believe that BP has a great deal of influence over the FDA.

Gary


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