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Re: HoundDogg post# 2768

Friday, 02/07/2014 2:49:36 PM

Friday, February 07, 2014 2:49:36 PM

Post# of 9945
Another thing I might add for your questions....and I am just speculating...but the FDA already knew all the data and what was where. Under the new label a different set of formatted data has to go with the application. I believe that when the FDA broadened the label, they also knew where they would get that data...over there...out of those 28 patient sub set. Now the way I think....and I am a puzzle guy by nature...that may mean the BTD is the least of what they can get...if ALL the data found suffices then it should be OA. One step down from that is saying we think its very safe and we will release it but run that short study at the same time...AA.

Without cheerleading....this is just how I think. If the FDA said "NO!" it would all be over at the last meeting. They did not so reading and rereading all the 8k's and pr's I try to put the puzzle together...Like asking "what is the FDA doing and what did they want when they changed it?"

Never just stare at the evidence and say "oh well"
Everything has a reason.
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