Getting Accelerated Approval
It's a game plan that could include obtaining accelerated FDA approval of its pancreatic cancer treatment if it can produce the same strong results in an announced Phase 2b clinical trial that were produced in two separate Phase 1/2 trials using the combination of the Cell-in-a-Box® technology with the anticancer drug ifosfamide.
oh yeah WE ALREADY DID THAT...beat out the other 2 standards...
The market may want to start connecting the dots with this international biotech because as Nuvilex releases each piece of its story, the path is leading to more and more impressive hands guiding Cell-in-a-Box® and Nuvilex right to the FDA's door.
oh yeah WE HAVE THE DR. WHO CAN TAKE US THERE....
Dr. Von Hoff is the World's Leading Authority on Pancreatic Cancer & Now He will Lead Nuvilex's Clinical Trials
Dr. Von Hoff Developed Eli Lilly's Gemzar®
Dr. Von Hoff Developed Celgene's Abraxane®
The same developer who has turned into an FDA Approval Machine. As the World's Leading Expert on Pancreatic Cancer, the FDA seems to approve everything Dr. Von Hoff touches related to the disease!!
What investors may not realize is that through the FDA's Accelerated Approval Program, Nuvilex could receive FDA approval of its pancreatic cancer treatment using Phase 2b data. If CNS can once again lead the combination of Cell-in-a-Box® with ifosfamide to the same powerful results it generated in prior trials that still today outperform Eli Lilly's Gemzar® and Celgene's treatment, the FDA could grant accelerated approval for the treatment. This program is one of several tools used by the FDA to expedite the approval of medicines intended to treat serious or unmet needs.
oh yeah...THE KEY WORDS ARE ONCE AGAIN....just like last trials...
The FDA's Accelerated Approval Program allows for the approval of an investigational drug or treatment based on a surrogate endpoint (a measurement that can "stand in" for an accepted measurement of disease progression) in early-phase studies if the condition is serious or life-threatening, and Nuvilex should have an excellent case for just such an approval.
If that were to happen, the company may or may not be required to conduct a Phase 3 trial while its treatment is being used by patients with advanced, inoperable pancreatic cancer. It would, however, undergo a Phase 4 or "confirmatory study" to further evaluate and confirm the efficacy and safety of the treatment, but it would do so with Cell-in-a-Box® combined with ifosfamide on the market.
oh yeah....PANCREATIC CANCER IS A DEATH SENTENCE....
that about covers it...
bull
