Yes, with a SPA and trial results known, approval is highly likely. Not sure what's holding back the price. It's unfortunate that Oppenheimer cut the price target by $5, given the report was so bullish. Makes for a misleading headline. I added another 100 shares at 33.50 today.
My guess is that the company has already been negotiating a deal in the EU, and that there will be an announcement prior to approval. The deal would have to be structured so that it is contingent on FDA approval.
I did notice that the analyst changed - the one doing the $60 price target isn't the same one who did the $55 price target. That might explain the use of the phrase "assuming coverage". I wonder if the new person wanted to keep expectations more reasonable, so the odds of beating the price target would be better.
..."Analyst Ling Wang commented, "We are assuming coverage of Relypsa, Inc. with an Outperform rating and $55 price target (previous Oppenheimer rating was Outperform with $60 PT). We view Patiromer as having the potential to change the treatment paradigm with the first-mover advantage to address a large unmet need of hyperkalemia."
"Given the compelling phase III/II efficacy/safety (data publication in JAMA and NEJM), we expect an outright approval with broad label and QD dosing by the PDUFA of 10/12/2015 (expect no advisory committee meeting). We expect a gradual ramp-up but long product life to peak in a newly developed market. Potential EU approval/partnership could drive additional upside."
Sentiment: Strong Buy
While like everyone else I think both drugs will be approved, as of now, the odds for both companies are less than 100%. Once RLYP has approval, then the probability shifts. RLYP's odds of approval will be 100% and ZSPH's will still be less than 100%. While that sounds nit-picky, investors factor it in.
I bring this up because there is more to the equation than just how big of a lead in the market that RLYP will have. There is no guarantee that ZSPH will get over the approval hurdle and even have the opportunity to compete. While it may not seem like a big risk, Wall Street will factor it in. We saw the short selloff in ZSPH when the NDA response was delayed...between now and next May, that can happen again.
And FWIW, RLYP's lead is currently 7 months not 6.
Sentiment: Strong Buy
Byron, it's the same model as the retail barcoding - DMRC will be paid upfront. Look at the point-of-sale at the retail store...when someone checks out at Wegman's, DMRC doesn't make anything on those sales. DMRC is paid when the individual sku's are registered with DMRC - that is done to make the checkout possible.
Ditto on a buy button - DMRC will not gain anything additional when someone clicks the buy button. DMRC will be paid when the products are registered. The invisible barcode is on a physical package - the other is on a screen that is tied to a physical product. DMRC will make clicking on a buy button possible.
FB would charge to place the ad, regardless of whether or not the buy button gets clicked. This may end up being a big driver for DMRC revenue, but I think we'll profit first from the in-store retail scanning application.
Your original post said nothing about manipulation. You said that if we don't rebound today - that is, we stay at 36-37 for a close today, then the stock will go to 32. There is no reason to believe that if we close at 36-37 today, that we'll fall to 32. The key is what mgt says tomorrow. That will determine the next move, up or down. Today's close is no more relevant than yesterday's, unless something dramatic happens.
I can't think they'd be scheduling all this if things weren't going well. We'll find out soon enough. It all starts with the conference call this week.
So much for there being a selloff due to a safety concern. There is no safety issue despite the FUD that some are trying to create here. "SAEs were reported for 44 patients (14.5 percent), none of which were attributed to Patiromer FOS by investigators."
So there were none - 0 - nada - serious adverse events attributed to the drug.
The trial's results were published in the most prestigious peer-reviewed journal there is, the Journal of the American Medical Association. It would not be surprising to see approval prior to the PDUFA date in October.
Medicaid may be more of a state and taxpayer problem than a problem for nursing homes. States aren't going to drive facilities out of business willy-nilly - if they did, what would they do with the residents then?
Plus REITs like OHI don't operate nursing homes - they own the property and lease it to the operators. So OHI does not have the same risk profile as an operator.
The operator has a mix of Medicare, Medicaid, and private pay residents. If they get squeezed on costs, they simply raise the rate on the private pay residents. Nursing homes are like insurance companies and casinos - they may lose on some residents but they know the odds, so they win overall.
Residents stay in long term care for less than 5 years on average, and assets can't be moved within that 5 year period. So on average, most residents have enough resources to cover the cost of their stay at the full pay rate. And with demand for long term care escalating due to baby boomers, nursing homes will be able to play that game of price-gouging the private pay residents for decades.
I haven't added to SNH, but I still own it. I have added to MPW. They have increased their dividend this year. MPW is not in trouble IMO. I do not own SNR, but I am looking into it.
OHI was already my largest REIT holding when I recently added to it. OHI has a yield over 6% plus they have had 12 consecutive quarters of dividend increases. Nursing homes are the sector to be in, IMO. My mother has been in a nursing home for 6 years - you have no alternative. Medicare reimbursement rates are almost totally irrelevant - Medicaid reimbursement could have a bigger impact, but IMO nursing homes hold the cards and they will be profitable "indefinitely."
...especially to ggrail who got me into this stock! I had to sell a big chunk on Friday, but not for my investment outlook on WYY. I'm getting older and excessive risk isn't my thing anyone. If we go to $3, $5,or beyond, I won't get rich. But already I'm "5 and 5" - 5 figure profit locked in and I still own 5 figure shares.
Also, I ran into a friend last year that I hadn't seen since jr.high. He bought WYY at 1.44 on my recommendation. After he did that, later I thought #$%$", I have no clue about his risk tolerance...what was I thinking, seeing the guy after 50 years and telling him to buy it?!
When WYY fell to the 1.20's, I was concerned and emailed him. He said he doesn't follow stocks day-to-day and he wasn't worried about it. He said he does a buy-and-hold if the DD was done upfront. So, he doesn't know it, but he owes ggrail a thank you as well! I will do the same at this point - whatever WYY does going forward, que sera sera since I am green no matter what. But I do expect my profit to grow!
I don't expect dramatic headlines either, Value. So you could be right that there might be a knee-jerk negative reaction. But I don't see how this story can be kept under wraps much longer. I added last week.
It will be interesting to see if there are Q2 revenues from either Shazam or Wegman's. But the key for me will be how close we are to customers 2, 3, and beyond for the invisible barcode.
There is no safety issue. There is no reason for the FDA to require an additional study. All newly approved drugs are required by the FDA to keep safety data after approval. That's no big deal. The stock price is ridiculously cheap. For Wall Street traders, 3 months is an eternity. It will start to move significantly higher prior to the PDUFA date.
The 1.4 billion is US sales only. They can license it overseas as well.
"...According to Moussatos, “Patiromer has the potential to be best-in-class and the first breakthrough treatment for hyperkalemia since 1958.” With that said, the analyst believes “it has the potential to fill an unmet need for [chronic kidney disease and [heart failure] patients with mild or moderate-to-severe hyperkalemia as well those on a suboptimal dose of a RAASi due to recurrent hyperkalemia.”
"Moussatos reiterates an Outperform rating on RLYP with a price target of $63, believing that the FDA acceptance of the NDA for Patiromer is “setting the stage for approval before year end 2015.With a small specialty sales force of about 100 reps, [Moussatos] project[s] peak annual sales of Patiromer could reach about $1.4 billion in the U.S. alone.”
Carnac was a good schtick, especially with Ed as the straight man. However, Steve Allen was bitter that Carson had stolen the idea for Carnac from Allen's "Answer Man" routine and had never acknowledged it.
Allen wasn't seeking money or anything like that, he was just peeved that Carson never given Allen credit for it. It would have been a simple thing for Carson to be gracious enough to acknowledge it...no one would have cared and it would have made for peace between two good comedians.
FWIW Allen had a lot of interests outside of comedy and wrote many books. I read "Dumbth" once...it was about the dumbing down of society. I wonder what he would think if he were alive today since the situation has become materially worse.
As for WYY, still long!
I am lowering my expectations for the conference call, but I think WMT is a near lock to adopt invisible barcoding in the near future. And we could get word of a retailer signing on before WMT does. Albertson's, Target, and Costco are all strong candidates. Albertson's had a former key exec join the DMRC board; Target signed a deal with Shazam, who is using DMRC technology; and Costco has already done flyer business with DMRC.
In the last conference call we heard that one "major retailer" was testing the invisible barcoding and had integrated it into their app. If it's Walmart, we're rich and just don't know it yet, lol! If it's Albertson's, Target, or Costco, that works for me as well. Imagine 2 major retailers signing up - and one of them is Walmart.
As long as Greece and China don't make a mess, we DMRC bulls should be rewarded soon.