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Re: saladan2 post# 48489

Sunday, 05/15/2016 11:52:51 AM

Sunday, May 15, 2016 11:52:51 AM

Post# of 144814
CEO Kenneth Waggoner has done a superior job accomplishing each milestone, as BioNewton has recently posted. Nobody here is going to be scared or bullied from their positions - we're going to be here for awhile. Moving forward, the pre-IND meeting is currently being arranged followed by submission of the IND application. Having said that, the company will apply for Fast Track:
http://www.stockmarketmediagroup.com/nuvilex-inc-coo-discusses-upcoming-phase-iii-pancreatic-cancer-trials/
"In addition, Dr. Crabtree says the company will apply to “Fast Track” the company’s treatment."

Fast Track could be announced anytime:
http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
"Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients."
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