LMAO, PharmaCyte isn't going to pr a bad event like withdrawing their orphan application because they couldn't answer some standard questions being asked. The funny thing is that ciab had ema orphan designation once already. Would think it would be cake walk the second time around. Nope looks like EMA has caught on. Last post of the day
2.1.6 Product for treatment of pancreatic cancer - EMA/OD/178/14 [COMP co-ordinator: B. Bloechl-Daum]
As agreed during the previous meeting, a list of issues was sent to the sponsor for response. The sponsor was asked to clarify the following issues:
• Intention to diagnose, prevent or treat
To establish correctly if there exists a scientific rationale for the development of the proposed product
for treatment of pancreatic cancer, the sponsor was asked to further elaborate on:
- details on the proposed product, in particular the rationale for the proposed formulation;
- details on the clinical studies, in particular patients’ characteristics and treatment protocols.
• Significant benefit
The arguments on significant benefit are based on a potential improved efficacy in the condition.
The sponsor was requested to further discuss the arguments provided for significant benefit and to elaborate on:
- the comparison of the results for the preliminary clinical studies with the current standard of care for a similar population in the context of current European guidelines.
In the written response, and during an oral explanation before the Committee on 9 December 2014, the sponsor discussed in particular two available preliminary clinical studies in patients affected by the condition. The COMP considered in particular that the positioning of the product vis a vis the currently available products was not clear.
In communicating to the sponsor the outcome of the discussion, the sponsor formally withdrew the application for orphan designation, on 11 December 2014, prior to final opinion.
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.
News 
Market Data 
Discover 
