PharmaCyte Biotech Inc (PMCB)

[Peacefulwendy]

No, they did not report it and it is possible that they did not withdraw. I came to the conclusion myself by reading the meeting notes from the EMA and the company's PRs regarding ODD designations.

We applied circa September 2014. The December 2014 meeting notes showed they had questions for some companies and then the January 2015 notes showed that 14 companies withdrew their application. There were no notes as to denials for pancreatic cancer so I did not see that as a real possibility. I would have liked a PR regarding the EMA ODD application status but once we received FDA ODD, it was not necessary and I saw it was possible that we just withdrew.

I personally think that once we got ODD from the FDA, we decided to focus on our studies with TD2. After all, those trials will be coming up first. Also, we were granted FDA ODD in December 2014.

Each link I provided below supports everything I mentioned above. It may look like I over did it on the links but I was just trying to show "good faith", mixer.

http://www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2015/01/WC500180405.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2014/12/WC500179564.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2014/12/WC500179288.pdf

http://www.dddmag.com/news/2014/10/nuvilex-applies-orphan-drug-designation-pancreatic-cancer-treatment

http://www.marketwatch.com/story/nuvilex-submits-application-for-orphan-drug-designation-to-the-european-medicines-agency-for-its-cell-in-a-boxr-treatment-for-pancreatic-cancer-2014-09-02

http://globenewswire.com/news-release/2014/12/22/693421/10113176/en/FDA-Grants-Orphan-Drug-Designation-to-Nuvilex-for-Pancreatic-Cancer-Treatment.html