Daily happenings?., page-224

Orphan Drug Designation has already been granted for PTX-100 in the US and is sort of separate to a Registration Trial. We are currently compiling the necessary documentation required for FDA approval for an accelerated / registration, @Tym1ng

SYC stated that we needed to recruit additional patients in order to provide a more "robust data package" for our FDA approval. He also stated that the data would be ruled off at the end of the year... in other words, regardless of ongoing recruitment rates and the status of the trial, we will be submitting the application for a registrational trial.

I'm doubtful that we'll receive any news on the PTX-100 front anytime soon. However, SYC did state that we have "stong newsflow coming".... when that will be is anyone's guess given that those words were uttered 6 wks ago in an interview in which he was beaming from ear to ear! CellPryme has been or is being evaluated by several 3rd parties (apparenttly). No news on that front can mean either nothing promising has come out of the evaluations or that evaluations are ongoing. Take your pick. The sound of crickets is deafening.... a far cry from the attention he used to lather on the market and SHs.