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pgsd

08/13/16 9:58 AM

#69696 RE: AVII77 #69695

Just a suggestion... you should start each post with "I speculate" because let's be fair you simply do not know. I suggest you wait to see as the trial concludes, confirmation of trials is announced and we are given updates on all other outstanding issues.
One thing for certain despite all the warnings of 'doom and gloom', all the false accusations, all the criticism etc. etc. behind the scenes the company are working hard diligently solving all issues one by one. Far be it the profile of a company about to go bankrupt as you would have many believe, It is a company with an important destiny. If you read the latest 10-Q objectively, in an unbiased way there are striking events in progress as follows:-


"During the quarter ended June 30, 2016, our research and development expenses were greatly reduced compared with the quarter ended June 30, 2015, as we are now past the peak cost periods in the Phase III trial of DCVax-L for GBM brain cancer, we expect the costs related to the Phase III trial to continue declining further as the trial moves toward completion, and we have completed the Phase I trial of DCVax-Direct"

"as well as undertaking product and process development, and preparing for multiple Phase II trials"


We are currently pursuing preparations for multiple Phase II trials. We expect that our research and development operating costs will remain at a substantially reduced level until the Phase II clinical trials are ready to proceed with enrollment and execution. We have implemented lower levels of fundraising while our research and development costs have been substantially lower. We plan to increase our fundraising activities as the upcoming Phase II trials become ready for enrollment and execution.


"We have expanded the personnel resources allocated to our Company’s work, and the activities performed for our Company, by the two external firms"


"We have recruited additional personnel, and we are in the process of recruiting further personnel, to enable still further segregation of duties and increased oversight"


Even recruiting extra staff and expanding whilst preparing "for multiple phase 2 trials" This is the profile of a company 'going places'































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Rkmatters

08/13/16 10:43 AM

#69698 RE: AVII77 #69695

MD mentioned Direct+CI. I could see a partial clinical hold extending to the same pharmacology products, but not to another. Direct is a different product altogether. Besides sites can't be trained unless a new IND (Direct + CI) was released. The last step is waiting for the IRC approval at sites to proceed. I think that is why you asked about 30 days, which is how long that process takes.

Going back to the RANO issue, you never actually admitted that RANO affects both arms. So your RANO psPD concern, like I told you, equally affects both arms. Silence. :)