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trazbull

02/22/13 8:47 AM

#38401 RE: Skelly22 #38399

that's the pr i would expect also...unless they get a green light prior to the 30 days as well as getting the green light on orphan/fast-track status!....that would be THE PR!!!! we all expect the approval.
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monkeypick

02/22/13 8:48 AM

#38402 RE: Skelly22 #38399

FDA never say deny an application in first time. they will say thay want more information one or two time before deny. if the want deny
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JCVitoV

02/22/13 9:02 AM

#38407 RE: Skelly22 #38399

I' not so sure about that, correct me if I'm wrong, but the 30 day process is to give the FDA a chance to deny/postpone. I'm definitely not assuming they'll deny, but could there be a decent chance that they'll postpone for further investigation?? Maybe they are notoriously inefficient and always take longer than 30 days to approve...i dunno, just contemplating...

Call me crazy here, but before we get to that thirty day mark, be prepared (don't assume) for a postponement, which will definitely cause a significant dip...whether it's protecting your initial investment or having cash ready to buy in for more or both, just be prepared...If the FDA is anything like the IRS, 30 days just may be a tight squeeze to finish their approval process...

FYI, I am long and STRONG on this (I have a gut feeling on good news coming soon), but I admit that I did secure my investment a while back by selling for a 25% profit, which happened to be only a quarter of my shares, so trust me, I still have a lot to gain/lose at this point.

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