The issue would have nothing to do with the treatment itself being approved. The issues are paperwork/legalities related only. Since it was after the IND application was submitted that the patent protection expiration was discovered, there would have to have been some additional filings by the company in order to ensure they are fully protected with the Oregon State patent they are utilizing in the HemXellerate treatment. The fact that the protection expired after submission, changed everything in terms of paperwork because the company would be forced to take additional measures to protect their product and the company.

Think about it, it is a status change. A status change can change everything in some scenarios...think about filing your taxes or doing business with your state. If your status changes then so does a whole lot of other things, especially paperwork. They are dealing with the FDA. You best believe they had to make some changes when this status for the patent changed.


As far as this having any bearing on the treatment itself being approved, no. The treatment is the treatment regardless and will be approved or denied based on efficacy, safety & further guidelines stipulated by the FDA governing the safe use of a treatment in human trials. The company confirmed that in the 31 July PR. 

BMSN---REGEN BIOPHARMA---HEMAXELLERATE---Min/Benitec