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Re: ThomasS post# 58937

Wednesday, 02/13/2008 9:51:11 AM

Wednesday, February 13, 2008 9:51:11 AM

Post# of 252366
INGN, the ADVEXIN NDA of course.

The orriginal gameplan had a few minor setbacks :

. The 2 P3 trials never completed enrollment
. The anyalysis of the aborted trials showed it failed

But this hasn't stopped INGN from it's glorious mission to bring ADVEXIN to market.

Alas, since then they had a few more setbacks :

. One trial has vanished from the face of the earth.
. The attempt to data mine a subset on the other trial failed.

So this caused a further delay, back to the data mining. It seams they are now trying to find more long term surviving patients to add to the subset of P3 deficient ones in the ADVEXIN arm.

And for over three years now the NDA has been about ready to be submitted!

The odd thing is that in the time they have spent on this charade they could have run a correctly designed P2 to see if the drug really works in the presumed subset they have in mind.

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