Not retired sessis...Just been around the block with four companies in the med fields that went public over the last 20 years and one that was bought out three months ago for 390 mil (only owned 2% of that one unfortunately). I know how the system works. Orwin et al screwed up bigtime by not doing in vivo DDI studies after getting some positive reads on a number of drug interactions in the in vitro studies. You cannot shortcut the FDA process and authority. That I know.They went for a fast and first FDA approval to get the jump on
ZSPH and it has cost us bigtime.Trying to get that BB reversed even after the recent successful in vivo studies is going to be very difficult. My guess is frankly that the FDA will want even more in vivo studies done
on a greaer number of drugs before reconsidering the BB issue. Hope I am wrong.
Don't be naive here. RLYP had no muscle with the FDA going into the PDUFA and they were made an example of. AZN has the muscle, and some of their "consultants" might have even served on FDA panel reviews. They will dot their "i's" and cross their "t's" you can bet on that.
Am I hopefujl that facts and objectivity will win out, and the FDA will do what is right?
You betcha. Do I have rose colored glasses on like so many here seem to have when it comes to
the ultimate outcome on May 26th. Not on your life.
Justa.....I'm with yah bro but I'm not sure about anything really. Just keep feeling the FDA can be bought and I'm not talking money or bribes or anything of that nature but something a lot more powerful....Influence. It is the quintessential "good old boys club" and AZN is the frat President...we were trying to pledge and got booted, and AZN is the housemother. Serioiusly...I keep thinking something is going to go very wrong at
that FDA hearing, and not in our favor either.
I mean we're only weeks away from the PDUFA and one has to presume the ONLY people who have seen all of the ZS9 year follow on data (such as it may be) is the FDA. It's not published nor commented on by AZN.
Who knows what the read out was on it .We may never know. All the FDA has to do is just ignore it. Say everything looks good. Same with the sodium/edema issues. Just say no evidence to say that was caused by ZS9 as lots of the subject had prior edema conditons andi issues via CHF. DDI...How can they go before the FDA with really no DDI studies. We did that with limited studies and got black boxed. FDA just might say no evidence of DDI with ZS-9 and that be that. Same with increased BP. Could say it was non related to ZS9.
I'm sorry but the FDA went out of their way to bag us on our PDUFA on DDI. Could have simply placed a warning on the label not to take other meds for 3 hrs from taking Velt and be done with it. But oh no..
They had to draw some black box around a ridiculous 6hr window that NO doc says is necessary,
just to screw us royally. Sorry..that's how I feel. Just don't trust them one iota.
Buyout? We don't want a darn buyout, and certainly not now. We're on the cusp of an FDA approved painkiller for surgery and other major indications that is stronger and far safer and less addictive than the current standard of care. What do you think that is worth? Morphine and related morphine addiction following surgeries will be a thing of the past..(unless illegally by drug sellers). Multiply how many surgeries are done each day across the US...Europe...Asia....and that is our market. That and not to mention non surgical pain
management which is even a larger potential market!
This one, unless things change drastically, could be an outright homerun if you are patient.
Sentiment: Strong Buy
Job well done in the NDA submission and before I expected it frankly.
Now PLEASE hit the ball out of the park on Gono...The silence there has me a tad on my toes so the sooner
you can release hopefully blockbuster results the better.
Thanks Silver and glad you had a great time! Nice to hear. We're all going to have to celebrate when this one goes to $15 plus and RLYP and CEMP hit new highs! Dinner will be on me for sure! Cheers....
All I know is that every time Orwin opens his mouth the stock tanks. But nothing can ever replace the "right race wrong horse" comment made 50% higher than it is today. That in retrospect was the all time classic.
You need to ask Warren Buffet if he "trades all stocks except those selected to paper his coffin"...lol
As for me....I'm not overly concerned about ZS9 v Velt..I think we win the chronic market hands down, and that will especially be apparent after May 26th. The issue to me is how large that market will become? We need to get physicians off the react to an event (HK/ER type treatment) to preventative treatment, and that takes time, money and education. Some of the newly approved CHF drugs have HK as a major side effect and cardiologists need to be educated on preventing that with Velt and being confident of no drug interactions at 3hrs.
Splitting a 3 bil dollar a year worldwide chronic HK market is much different than splitting one that has
500 mil in potential. Actually AZN getting out and educating doctors and hospitals on the need to chronically treat HK will benefit us both. Time will tell.
You will soon find out in May why I was bashing ZS-9. ZSPH got lucky and got bought out by AZN looking for something "hot" to jump start a rather weak drug pipeline. The leaped before they looked too closely and will be punished badly for not doing proper DD. Trading is something you do until you have real money. You may find that out some day if you're lucky.
Eatonshorts moron...First of all it is quite likely I have more in this stock than your entire net worth and have since day one of it's IPO. I started this friggin board idiot stick. I know as much about this company and their science than most of the docs posting here, so you Johnny come lately nothings only add the pom pom posts which I try and ignore.
Vifor Fresenius through the Galencia Group which controls them may well end up bidding on RLYP. I do not discount that. But if they do not, selling to another big pharma is not going to be easy unless we pay a King's ransom to undo this deal and Galencia knows that. They have us by the balls frankly.
I'm not advising anything to anyone. Simply making an observation. It was a dumb deal.
Let's be clear here. I am very bullish on RLYP and have been since day one of it's IPO. They have the leading and perhaps the only FDA approved chronic treatment for HK. IMHO a US buyer of RLYP will not be so concerned about the EU arrangement simply because the US is by far the dominant market. Logistically and structure wise better to have an EU partner. Forget Japan. That is a regulatory and cultural nightmare
for any new US drug seeking to do business over there.
An EU buyer does not have the logistical concerns we would. The product, (Veltassa), is manufactured in Europe (Austria). BP in Europe knows the commercial and regulatory markets far better than we do.
They know the EU consumers better...the doctors views....the differences in various countries insurance and reimbursement rates and procedures, etc.
But an EU buyer like an AZN is NOT going to buy us to get some royalty payment regardless of how high that is. They want complete control over the asset and the hopefully increasing asset value over time. They want the ability to effectively account for the assets in a manner that would be tax beneficial for them. They want to own the assets as hopefully they will increase in value over time.They are not going to pay he same for full US rights but a limited royalty right for the entire EU.That is a fact.
Just look at the action today. We file for EU approval and the stock goes down? Now why do you think that is? Cause it implies that there is no EU buyer or perhaps even a US buyer involved right now otherwise it would make sense for us to hold off filing for approval through Fresenius would it not? Common sense gang.
!B in sales in the EU in "several years"? Give me some of that stuff you're smoking as I could use some right about now. We have a "cow" using cash, not vice versa. A European company who may be interested in us does not want a 22% royalty on sales in the EU. They want the entire EU market and the entire gross revenues. They want to control mfg and sales 100%. No wonder you were "fired in 2010"...lol!
No EU company is going to buy us as long as Fresenius controls all EU sales and gets the bulk of the profits.
That takest alot of potential acquirers, including AZN,out of the picture unless they buy Fresenius out of the dumb deal we made with them .Today's announcment of their filing for EU approval on our behalf means they're still very much in the game here and in compliance with ourr "give away" deal with them. Guess we're now back to the MRK rumor.
Nice find. No long term data presentation and solely acute focus. Would only cost AZN 1.8 billion more and they would have it all to themselves and won't have to explain to shareholders 2.7 billion down the drain.
Need to undo the Fresenius deal though if they are the buyer's. AZN is not going to have them control European sales and reap the bulk of any profits.
I won't bite until the darn CEO comes out and makes a statement that they are retaining IB's to review various preliminary proposals to acquire the company. Not going to be suckered in for the fourth time.
Oh no not another "rumor" that the company will neither admit or deny. Problem is now the rumors are going from lower lows rather than higher highs. Shorts not going to make a much each time one of these "rumors" fails come to pass. I guess "no comment" is Orwin's latest tactic as CEO to rally the stock?
Did these folks ever think that the best "incentive" they can give their employees is to actually make the company successful? That way they KEEP their jobs. Should that not be incentive enough? And since this is a one drug company that is already approved with an outside marketing team that is WAY over paid anyway,
what the F do most of these employees do anyway? Certianly not shareholder relations. Certainly not selling any product cause no one is doing that. Maybe the lunch room is a hot spot for pick ups, who the heck knows.
How about giving a million dollars to any employee who actually introduces a buyer for this company?
Now that would be money well spent!
Mastro's (Ocean Club) is the best steak house here in Newport Beach. It's all good but I always have the NY strip. Make sure you get the dessert that has some sort of cake and fresh fruit topping. Getting a good table is important. If you don't like where they sit you ask for another place. The bar is a hot spot for the pick up crowd over 40 so good people watching, but if you're at all decent looking and over 55 the women will be all over you walking to the men's room! Enjoy. PS The original Mastro's was in Beverly Hills and much smaller and intimate and done Frank Sinatra style including the music and pictures on the walls etc. I liked it better but a much longer drive so not worth it!
You guys really arguing about 2600 v 4000 patients now on Velt after 4 months?
The US has 320 million people and 3 mil of those were supposed to be able to benefit greatly from Velt. We have more in the combined sales forces than the script increases each month thus far.
We need big pharma to buy us and "bundle" Velt within any number of the drugs they sell to hospitals and physicians. They can do that. We do not have that option as we're only selling one drug. There is no way this company makes it going it alone. Numbers will never match up. This is Econ 101 and Statistics 101 folks and the guy running it I don't think ever took either frankly.