tna I beieve the first announcement re P3 CT for PC will be the CRO. Then they will need time to do their work before the actual start of the trial begins. However, IMO OTHER annoucements will be made regarding the treatment of Diabetes. That may well be an announcement of partnership with a mid to large sized pharma. Other announcements this year will surely include news of research for the use of #$%$ for the treatment of brain, breast and other cancers and illnesses where the cell encapsulation delivery system makes old drugs and new ones more effective, with fewer side effects. Those new to Nuvilex should understand that Nuvilex provides the delivery system - the "Cell in a Box" technology and not the drugs being administered. Nuvilex is working with drug companies, not competing with them, except for the Pancreatic Cancer treatment where we are competing with Lily and Celgene.
I don't expect P3 CT for PC to start anytime soon, (maybe Fall 2014) but there will be milestones which will provide PPS appreciation such an the announcement of a CRO (Contract Research Organization)
Likely partnership for the research and development for the treatment of diabetes using encapsulated cultured, insulin producting live cells. (The artificial Pancreas concept)
R&D partnerships utilizing cannibinoid components from mariunana for the treatment of brain, and other cancers.
and there's always the possibility of a partnership with a large pharma, or a buy out.
Nuvilex had nothing to do with studies in early 2000s, that was Austrinova.
Studies were done in Germany so no reason to involve the FDA. If you are serious about getting truthful answers contact Dr. Crabtree at Nuvilex. His 40 years experience in the cancer arena qualifies him to answer your questions. Seriously contact him - he will answer you.
esusun - I do hope things move along faster, I was hoping trials would start in June 2014, but now I'm not so sure. We can all agree it will take 1 year from the time the trials start because one of the metrics is 1 year survival stats.
Other variables to support and raise PPS
Short squeeze above .35
Lincoln at .25 gurantee
News re diabetes CT
News re MJ research funding
just plain mo mo and many will not
want to miss out of relative low prices.
To lower PPS, lack of news for an extended period of time.
It will take a lot of time and effort for NVLX. Selecting CRO, then CRO setting up the multi-country locations, doctors, writing and filing FDA protocol, enrolling patients, distribution of encapsulated cells and other things I don't even know about.
Estimate to FDA decision
Just my estimate and I hope things develop faster...
Preparation to do phase 3 to the end of 2014
(CRO, Cells, Patients enrolled)
Phase 3 begins February 2015, one year study
Phase 3 ends February 2016
FDA Decision June 2016
Likely mid 2016 for FDA decision, as I don't think the year long study will start until 2015. Hoe it's sooner.
Also consider Dr. Crabtree's long career in the cancer arena to include his employment at Bristol Myers Squibb and his involvement with developing Taxol. His confidence in Cell encapsulation brings me confidence in the furture of Nuvilex.
The road will be long however...
I don't expect Phase III for Pancreatic cancer to start before early 2015, then 1 year Clinical Trial then FDA
evaluation - so I think we are looking at mid 2016 before FDA decision is made. This is just my guess of the timeline - of course I hope it will move along faster - and that a Phase 1 for Diabetes is also started using cultured insulin producing encapsulated cells. (Not islet cells from pigs or dead people)
Would be interesting to know if approval processing takes more or less time in countries outside the US and FDA