How much longer until RVX-208 goes to market? I just listened to the December 12, 2017 Webcast again. Slide 19 indicates that top-line data for the Phase III BetonMace trial occurs in Q4, 2018, only 9-11 months from now. Presumably, an NDA will then be filed provided RVX-208 is safe and effective as verified in the trial. Having begun this journey in 2001, the company is finally reaching the endpoints. 

The narrative below was lifted from Investopedia. We are ending stage 6 of the new drug development process with full enrollment of BetonMace PhaseIII expected during the second quarter. Coincidentally, Resverlogix is right on target with $350MM invested in developing this new drug. It's now time for BP to pony up. They have been leveraged thru the development process, on the sidelines, while RVX shareholders have carried the cost and risk of development - a feat deserving substantial premiums if successful, typically at a cost of $5Billion if BP were developing this idea themselves (see below).  BP scoops this goldmine up by the end of this year. It's time to get the wonder drug to market. Who is it going to be?

Best Wishes to all :-)

Chicagoest

"Once a company reaches the NDA stage, the probability of the drug receiving FDA approval and being marketed in the U.S. exceeds 80%. Filing of an NDA typically does not result in a substantial increase in the share price of the sponsor company, as most of the stock appreciation is likely to have occurred as the investigational drug progressed through successive phases of earlier clinical trials."

"A study by Forbes in August 2013 established that a company hoping to get a single drug to market could expect to spend $350 million before it became available for sale, while large pharmaceuticals that work on numerous drug candidates at a time spend as much as $5 billion per new drug."

BREAKING DOWN 'New Drug'

The process of getting a new drug to market involves the following steps –

1. Development of a new drug compound
2. Animal tests for toxicity, to ensure the compound is safe for humans
3. Investigational New Drug (IND) application to the NDA
4. Phase 1 clinical trials or studies, where the emphasis is on the drug’s safety and side effects
5. Phase 2 clinical trials, where the focus is on the proposed drug’s effectiveness
6. Phase 3 clinical trials, which are very large, multi-stage trials that gather more information about the drug’s safety and effectiveness
7. New Drug Application (NDA) to the FDA, which is a comprehensive document containing all the above information
8. NDA review by the FDA
9. Drug labeling review and facility inspection by the FDA
10. Drug approval (or rejection) by the FDA

The FDA’s Center for Drug Evaluation and Research (CDER) is the specific body within the FDA that is involved with reviewing the new drug development process. The CDER has in-depth understanding of the science used to create new products, testing processes and manufacturing procedures, and the diseases and conditions that are sought to be treated by new products, and provides the scientific and regulatory advice needed to bring new products to market.

A new drug candidate can fail at any step of the process, because the clinical trials are meant to establish unequivocally that the drug is safe and effective in treating the targeted indication. Since 95% of experimental medicines fail to be both safe and effective, the cost of new drug development has been spiraling upwards for years. 

Read more: New Drug Definition | Investopedia https://www.investopedia.com/terms/n/new-drug.asp#ixzz53XGs4axH