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MGaddy

10/22/14 3:40 PM

#194806 RE: Protector #194805

"I think, and that is my personal opinion, that Garnick has just adhered to the scenario DEC 2016 is DEC 2016. And in that scenario there is no room for any form of early 'whatever', whether it is early end of enrolment, early reporting on enrolment, early approval due to a look in, etc. Just wondering WHY!"

I think they would rather state as fact that the trial will end in Dec 2016, because they KNOW that worst case it WILL end in Dec 2016. If we do get some sort of approval on an early lookin or DMC stoppage then they(and we) look great. But until then go with what you know you can do, leaves room for surprises not disappointment.

MG

vanessapu

10/22/14 3:47 PM

#194807 RE: Protector #194805

I guess we are better off ,selling half of our investments and putting in the bank and earning zero for next two yrs?
We had a greater margin of spreads in the past and for us layman we were able to make a profit now the spreads are there for professionals .

Robert C Jonson

10/22/14 3:59 PM

#194808 RE: Protector #194805

CP, I think Garnick thinks Bavi is safe. I think he was just saying when you have the greater numbers of a ph III, surprises do happen.

Bob

geocappy1

10/22/14 4:32 PM

#194817 RE: Protector #194805

IMO they did not want to wait for 150-200 patients to see if the trial was on track (no sabotage). I think they learned their lesson. I wouldn't be surprised if the 1st lookin is based on 100 patients. I do not think that is enought o get them stat sig (they needed 80 on the treatment side in phII).

I think they will go after stoppage on the 2nd lookin using 175-200 patients to be sure they get the stat sig. based on phII if they don't get stat sig with 100/100 patients on the CG/TG then there might have been a problem with our phII. However, if phII was good it would seem we would see clear data at 200 patients. it would be silly to have any lookin after 200 patients because we are only talking another year after that for completion.

So, I think they were thinking 1st lookin is very early and making sure we are not getting screwed by anybody. 2nd lookin is as early as possible but to make sure we have the data we need. The dog and pony at the ASM was saying leave us alone if you don't hear anything til Dec 2016.