I think now Nuvilex is moving into institutional hands, with less hedge funds - Institutions bring stocks down to scare people out of their shares also so they can buy a lower levels.
I'd email Nuvilex, attention Dr. Crabtree - and I'd say Dr. Crabtree is the SAB for Nuvilex. 40+ years in the cancer arena - brought Taxol to market when he worked for Bristol Myers. If you haven't already done so, suggest that you read the bios of the management at both Nuvilex and Austrianova websites.
I could be wrong, but I am expecting a partnership deal with a major pharma regarding the treatement of diabetes. Why else would that have acquired the rights, and now have paid for it 2 months early. See 8K
Bristol Myers Squibb's Ifosfamide (IFEX) a FDA approved chemo drug is already used to treat several kinds of cancer.
But since cell encapsulation decreases side effects dramatically, I would think doctors and patients would
use Ifosfamide via encapsulation pro drug, instead of depending on the liver to turn Ifosfamide into its cancer killing drug.
The process developed by Autrianova encapsulates live cells.
Think of Nuvilex as the conductor of a large orchestra, and the musicians are the many relationships and partnerships which will provide the music. ie sucessful research and implementation of treatments using live cells.
Scaling up - Partnerships will scale up on their own. Remember Nuvilex provides the delivery system and will not invent new drugs.
After phase 3 is finished, in 2016 or so, and FDA approves that treatment, cell encapsulation, the delivery system, will be validated and more and more uses for cell encapsulation will be developed. I expect the a partnership will be announced soon, with a pharma for the research into using insulin producing cells to treat diabetes. Go to the Austrianova and Nuvilex websites - learn what they do, and how they are working together - and read the bios of the management of both of these companies.
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