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Replies to post #32748 on Grapefruit USA Inc (GPFT)

Replies to #32748 on Grapefruit USA Inc (GPFT)
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Denunzio36

11/26/10 2:31 PM

#32750 RE: KingKong_Guru #32748

Thanks Guru.
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Denunzio36

11/26/10 2:33 PM

#32751 RE: KingKong_Guru #32748

If they go MWE, whats the time frame looking like in your opinion?
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Dr. Mugs

11/26/10 2:37 PM

#32752 RE: KingKong_Guru #32748

KK Guru....Do you happen to know if the radiologists viewed the testing "live" or they just gave an opinion of the compared images. I get the feeling that Dean did all of the test himself and then just showed the images to the radiologists. If they did not send in the financial info on what they paid the doctors, then the FDA would not consider their opinion. Maybe, if they had underwriters laboratories do the testing instead of the radiologist then maybe we would not be in this NSE position. Now I feel the only route the FDA will except will be the IDE/PMA path.
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mr_sano

11/26/10 2:38 PM

#32753 RE: KingKong_Guru #32748

Are you saying they will not change the predicate? Wasn't that the primarily reason for the NSE? So round 1 was NSE which took 3 years. Round 2 will be a re submittal under the guidance of paid advisors. What is the time frame to pull this off? They have less than 6MO operating cash.