Grapefruit USA Inc (GPFT)

[kimble1]

ask them what?? this is what they decided....Dean mentioned in conference calls that by putting units in the field (ie: taking advantage of the IDE approval) he would open himself to more questions from the FDA and increase likelyhood of PMA route

basically the FDA would say since you have units in the field and are gathering data you should go down the PMA route



it was simply a strategic decision NOT to take advantage of the IDE approval....i think in hindsight it was a mistake...but it is easy to point out mis-steps after the fact

so i dont fault them...but i think it was a mistake

i do fault them for not using a 510K consultant...that was a big mistake...YES i understand they might not have had the money....you tell me what a better use of the money is

510K CONSULTANT
or
Money TV

kimble