BearDownAZ

Once again,  your comments and analysis are greatly appreciated.

Chicagoest

SanFranciso99

Here's a little more kerosene for the fire:

Evidently, President Trump is favoring big changes at the FDA including speeding the approval process for new drugs to temper BPs hold on the market and to get life saving cures on the market more quickly. See the highlighted paragraph below. There will be a lot of pushback from the Democrats on this but Trump is committed to lower health care costs and this could be great for RVX-208 which already is in a Phase III trial with two positive safety board recommendations and today's announcement. 

It seems to me,  that if in fact RVX is safe and already has been tested in over 1,000 patients before the Betonmace trial, and has been allowed to continue dosing after being administered to another 1200 patients since the Phase 3 trial has begun, this will be an excellent candidate for the new FDA approach. A drug that can be administered at ~ $4,000 per patient per year that has shown significant MACE reduction in it's previous trials,  and considerable positive effects in the study released today, we need to get this on the market more quickly.

The Canadian Prime Minister meets this week to discuss NAFTA with Trump , among other issues.

Positive things are beginning to happen - DYODD and Best Wishes to all 

Chicagoest

Letter From The Editor: Huge Change For FDA

BY DAN FLYNN | JANUARY 15, 2017

OPINION

Something huge is going to be happening soon at the U.S. Food and Drug Administration (FDA). There’s lot’s of chatter about it. From a “Coming Political Hurricane” to a “Libertarian Take-over,” it is all anticipation about the transition of government.

FDAAproved_406x250Most of it seems to be directed at drug approvals and medical devices, not food. Many weeks ago, the Trump campaign did post  a “food police” page on its website that was apparently some type of food freedom creed, but it was quickly taken down.

The chatter about drugs and medical devices is increasing,  not going away. In fact, it will likely increase this week as FDA Commissioner Dr. Robert Califf steps down and is temporarily replaced by Dr. Stephen Ostroff , who last June replaced Mike Taylor as deputy commissioner for food and veterinary medicine.  He now fills in as acting commissioner.

That  Dr. Califf, one of the nation’s most renown cardiologists, won’t see his first anniversary as FDA Commissioner, when  he was willing to continue,  shows just how much FDA is changing.   FDA has long been led by reknown scientists and medical doctors. All those degrees are not going to mean as much.

That’s because the only prospective candidates for FDA Commissioner are from the world of venture capital,  a sector that plays a big role in drug development. Trump is said to be looking for new thinking to change government from Silicon Valley billionaire Peter Thiel. He’s been calling for bold action.

Thiel owns Mithril Capital Management, where Jim O’Neill is managing director and an apparent candidate for FDA Commissioner.

Another is Balaji Srinivasan, a partner in the venture capital firm Andreessen Horowitz. Both met with Trump as recently as last week. A third possibility is former FDA deputy commissioner Dr. Scott Gottlieb, now a resident fellow at the American Enterprise Institute.

Where this may be going is a “Back to the Future’ move. Dr. Andrew von Eschenbach, President George W. Bush’s second FDA Commissioner, came up with the progressive system to speed drug approvals. It eliminates the costly stage 2 and 3 drug trials that often require promising drugs to be sold before they are approved. Progressive approvals are used for some drugs in japan, but the idea was killed here by Big Pharma.

There are several steps that must occur before any of this plays out. First, the Senate will have to complete action on  Rep. Tom Price’s confirmation as Secretary  of Health and Human Services. Next, Trump will have to nominate the next FDA Commissioner, who will then be subjected to the kind of examination that the cabinet appointments have gone through. How the Senators feel about quicker approvals is certain to be tested.   Are they going to be faster approvals, which are popular with some patients, or are they going to remain in the comfort of Big Pharm.’s pocket?   Oh  yes, it will get played with such harsh portrayals.

Only after the new FDA Commissioner takes command will the ponderous process of any changes actually begin. Until then, there’s sure to be more speculation. The likelihood is that any turmoil that lies ahead for FDA won’t have food at the front and center.

It should instead be able to get about  using  the Food Safety Modernization Act, preventing foodborne illnesses, and ignoring the noise that may be coming from other parts of the agency.

© Food Safety News

More Headlines from Government Agencies »

Letter From The Editor: Huge Change For FDA

BY DAN FLYNN | JANUARY 15, 2017

OPINION

Something huge is going to be happening soon at the U.S. Food and Drug Administration (FDA). There’s lot’s of chatter about it. From a “Coming Political Hurricane” to a “Libertarian Take-over,” it is all anticipation about the transition of government.

FDAAproved_406x250Most of it seems to be directed at drug approvals and medical devices, not food. Many weeks ago, the Trump campaign did post  a “food police” page on its website that was apparently some type of food freedom creed, but it was quickly taken down.

The chatter about drugs and medical devices is increasing,  not going away. In fact, it will likely increase this week as FDA Commissioner Dr. Robert Califf steps down and is temporarily replaced by Dr. Stephen Ostroff , who last June replaced Mike Taylor as deputy commissioner for food and veterinary medicine.  He now fills in as acting commissioner.

That  Dr. Califf, one of the nation’s most renown cardiologists, won’t see his first anniversary as FDA Commissioner, when  he was willing to continue,  shows just how much FDA is changing.   FDA has long been led by reknown scientists and medical doctors. All those degrees are not going to mean as much.

That’s because the only prospective candidates for FDA Commissioner are from the world of venture capital,  a sector that plays a big role in drug development. Trump is said to be looking for new thinking to change government from Silicon Valley billionaire Peter Thiel. He’s been calling for bold action.

Thiel owns Mithril Capital Management, where Jim O’Neill is managing director and an apparent candidate for FDA Commissioner.

Another is Balaji Srinivasan, a partner in the venture capital firm Andreessen Horowitz. Both met with Trump as recently as last week. A third possibility is former FDA deputy commissioner Dr. Scott Gottlieb, now a resident fellow at the American Enterprise Institute.

Where this may be going is a “Back to the Future’ move. Dr. Andrew von Eschenbach, President George W. Bush’s second FDA Commissioner, came up with the progressive system to speed drug approvals. It eliminates the costly stage 2 and 3 drug trials that often require promising drugs to be sold before they are approved. Progressive approvals are used for some drugs in japan, but the idea was killed here by Big Pharma.

There are several steps that must occur before any of this plays out. First, the Senate will have to complete action on  Rep. Tom Price’s confirmation as Secretary  of Health and Human Services. Next, Trump will have to nominate the next FDA Commissioner, who will then be subjected to the kind of examination that the cabinet appointments have gone through. How the Senators feel about quicker approvals is certain to be tested.   Are they going to be faster approvals, which are popular with some patients, or are they going to remain in the comfort of Big Pharm.’s pocket?   Oh  yes, it will get played with such harsh portrayals.

Only after the new FDA Commissioner takes command will the ponderous process of any changes actually begin. Until then, there’s sure to be more speculation. The likelihood is that any turmoil that lies ahead for FDA won’t have food at the front and center.

It should instead be able to get about  using  the Food Safety Modernization Act, preventing foodborne illnesses, and ignoring the noise that may be coming from other parts of the agency.

© Food Safety News

More Headlines from Government Agencies »

I may have missed this on the RVX Agoracom Board - has anyone discussed the similarities and differences of the mechanismof action of these two drugs on the board?

I recently watched a 60 minutes segment on Alzheimers which cited a research study in South America identifying a town in Puru or Chile I believe where many of the inhabitants had early Alzheimers onset. After studying their DNA, they could identify and predict those suceptible to early Alzheimers.   

Merck recently had a similar announcement on Verubecestat - "which blocks the enzyme BACE1, which pays a key role in the production of two molecules that link together to form the amyloid plaque. It is noted that people with BACE1 gene mutation are resistant to Alzheimer's disease. 

However, this is not the first drug to target BACE1, since a number of attempts made earlier aimed at inhibiting the emzyme failed as a result of aside effects that included eye problems and liver toxitity. The clinical trial by Merck involving Verubecestat is the first large scale trial conducted for Alzheimer's by far and the drug is said to have fewer side effects than those tested. 

It is reported that the drug is being tested in 1,500 patients in very early stahges of Alzheimer's disease and 2,000 patients suffering from mild to moderate levels of dimentia.  The results of the first phase of these trial are expected to be out in July 2017.

People are excited, said John Hardy, neuroscientist at University College London who first reported the role of amyloid plaque in Alzheimer's disease."

Epigenetic research is getting more and more positive attention. and is now at the cusp of recognition as the next wave of blockbuster drugs. It appears that RVX has overcome the toxitiy and safety issues and is well positioned with its patents, trial data, multiple clinical trials in progress, blood bank ... to finally get these new drugs to market.

My question to the scientists, doctors and researchers on this board - Is it possible that RVX-208 would improve the function of Verubecestat similiar to it's synergy with Rosuvastatin? - 

"Apabetalone, a bromodomain extra-terminal (BET) protein inhibitor, inhibits BRD4, thereby regulating the expression of genes and restoring the function of pathways underlying the pathogenesis of CVD " - See Slide 16 Biotech Showcase 1/9/2017.

This was a wonderful way to start out the week - 

Chicagoest

Narmac 

We are both on the same page - the good thing is that we are nearing an end to this epic story and closing in on the final chapter. We should know the answer sometime in the next 24 months. I feel like Dr Zhivago trudging through the Siberian winter. Hopefully we have a happy ending.

On a personal note I see you are from Halifax. I have seen Natalie McMaster perform live at the Philadelphia Folkfest several times, What a beautiful and wonderful talent - she always lights up the stage with her energetic performances.

Here's to RVX in 2017 - Lets hope that Santa hasn't moved to the Carribean yet.

Chicagoest

SF

I agree with your post and share your sentiments. Recently, I tried to post a copy of an article written in the WSJ on 12/24/16 entitled Minority Shareholders Wise Up In 2016 by Holman W Jenkins, Jr.,  but had difficulty posting it and abandoned my effort. If you subscribe to the WSJ it was in last weekends publication. 

The jist of the article was "Caveat Emptor"

I'll retype the final paragraph:

"Some bits of advice become cliches because they have to be repeated over and over: Trust but verify. Fool me twice, shame on me. These are elements of eternal wisdom that investors can console themselves with when they get on the wrong side of controlling shareholders."

I suspect that potential suitors may have issues with the package, or whats left of it. RVX has much to offer but has already alllocated portions of the harvest to a chosen few. The Zenith spin-off sent much of the IP to Zenith thus diluting the package.  The Royalty Agreement is unconventional. The Eastern loan guarantee and Hepa deal enabled R&D and the trials to continue, but at what cost? A valuation or price was presented by DM which supposedly BP agreed with - True Value is a price at which both buyer and seller agree. Both the IPO for Zenith and US Nasdaq listing seem to have been abandoned - too costly? What's going on with the FDA?

RVX is on its way to generate billions in revenue if it meets the endpoints - will minority longs  be rewarded for our foresite or is this another case of trickle down economics?

CAVEAT EMPTOR

BEST WISHES TO ALL FOR A HEALTHY, HAPPY AND PROSPEROUS 2017 - MAY ALL RVX SHAREHOLDERS BE REWARDED 

Chicagoest