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Re: AngeloFoca post# 17881

Thursday, 09/22/2016 7:14:10 AM

Thursday, September 22, 2016 7:14:10 AM

Post# of 38634
Angelo.....its not me misleading anyone. All I am doing is pointing out what the company has publicly stated. and then also pointing out what the company can legally do if they choose. the company had 1 IND. the company put out a PR stating they HAVE ENHANCED their Rexista with PODRAS. they put out a PR that they received fast track status for PODRAS. All the nay-sayers were wondering why the company needed to do a 4th phase 1 trial hinting they were having problems. duh, its because they changed the formula and they needed to prove it was safe. The company has said they can file an NDA-S if they choose for PODRAS. Doog himself confirmed that and relayed that on this forum. just like any lawyer, I lay out the facts and then in summation I draw a conclusion. the company can add anything they want to their Rexista formula and file the NDA as long as they do all the safety trials and prove the BE. they only filed 1 IND but yet discussions with the FDA included PODRAS. they can most certainly add PODRAS to the formula and as long as they dont make any claim concerning it, they are just marketing Rexista. the same as if they just add a vitamin to the formula. once they want to make the claim that Rexista has overdose protection, they need to "prove" that statement and that can be done through the NDA-S pathway. a much shorter timeline than starting over with a new NDA. because of this the PODRAS patent becomes integral part in any discussion for partnership as well as why they need a number for filing so they can add the patent number on the application. now, if you would like to debate this, tell me what is misleading here.