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Keryx Biopharmaceuticals Inc. Message Board

mgm2020 379 posts  |  Last Activity: 5 hours ago Member since: Mar 3, 2010
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  • from here. And with 20 million short shares that were expecting the FDA to reject Nuplazid, or at least come out with a much stronger black box warning(the "warning" isn't even specific to Nuplazid, doesn't refer to any problems with PDP patients, and only refers to elderly patients with dementia treated with anti-pychotics)----they stand to see tremendous losses if they don't cover ASAP. I can't remember the last time any new drug was approved that had NO OTHER APPROVED COMPETITION and was much more effective and safer than anything being prescribed off-label? This is a rare situation in modern medicine and will turn out very well for ACAD and the shareholders. Anything under $40 will still be a double by the time the company is sold.

    Sentiment: Strong Buy

  • Because I believe that the technology is as good as they say and as valuable to cancer therapyas the studies have shown. The COMPANY is what owns the science, technology, and IP. It is NOT the CEO. It is NOT the CCO. It is NOT any one specific employee or pair of employees. The sell off due to the political shake up at the company is TOTALLY overblown and presents a fantastic b buying opportunity. Will insurers back out because the company has a new CEO? That sounds ridiculous---right? Will oncologists that have experience with the PCM tests and have seen the results improve the outcomes for their patients stop using it because Schuh and Posard are being replaced? Did they have a direct relationship with either of them? NO. Will Welch be able to continue the positive trajectory that TROV had been on through the beginning of this year and either bring in a new CCO or take on that responsibility himself successfully? I think that will be no problem. And will the sales and marketing team, as well as the insurance team(separate departments and executives) do exactly what they are supposed to do without 2 executives(1 who's already been replaced and 1 who had only been with TROV for a year)-----ABSOLUTLEY. There is my thesis and justification for saying that the stock has been overly beaten down.

    Sentiment: Strong Buy

  • better label and much more generic "warning" than anyone expected. The approval has been about as positive as possible but due to the overall mistrust of the FDA and the possibility that they may not follow the overwhelmingly positive vote of the ADCOM, the stock was held in check-----AND-----many risk-averse longs and other "negative" leaning biotech "geniuses" decided to short ACAD as both a hedge(not necessary and will now be costly) and a bet against approval(VERY bad decision). This was done while the Baker brothers ADDED another MILLION shares to their holdings following the adcom vote. IF you sell now you may face a PCYC-type event when the stock will double or more within a few days or weeks time as it approaches a buyout. That COULD happen at any time, and I am sure that the company has already been approached by at least one company just to test the waters and get some kind of idea as to where management would legitimately start considering offers. With $500 million in the bank and a fully hired and ready-to-go sales force, that offer would have to be NO LESS THAN DOUBLE the current stock price, and the sales numbers of Nuplazid will SHOCK the medical and analyst community as they come in WAY AHEAD of every estimate thanks to the lack of any approved competition-----an absolute rarity in modern medicine. I believe that any buy under $40 will still be a double---or more----with the company being acquired fairly quickly.

    Sentiment: Strong Buy

  • and nothing specific to Nuplazid or PDP and any side-effects or cautions. About as vanilla a "warning" as possible. And one story I read stated that the FDA has "asked" Acadia to include the warning----not made it mandatory. That I have never seen before. "Asked" for a warning??

    Sentiment: Strong Buy

  • Reply to

    pre-market $40+

    by kenzack714 13 hours ago

    And with 20% short------OOH---they are in BIG TROUBLE!

    Sentiment: Strong Buy

  • The ONLY FDA APPROVED medication for Parkinson's disease psychosis----the ONLY ONE!! Physicians will be COMPELLED to prescribe this for ALL of their PDP patients. And after they see how well their patients respond and hear first hand from their caregivers how much THEIR lives have improved----then they will also prescribe it for other conditions such as Alheimers psychosis. This will NOT be your typical drawn out ramp up. This will come roaring out of the gate, and if the company has to provide samples at first during the short time it will take to have Nuplazid added to EVERY DRUG FORMULARY----then that many more people will convert to full paying prescriptions as soon as it is covered. NUplazid will SAVE insurers and the health care system money by preventing patients from needing to be hospitalized during their psychotic episodes and breakthroughs. If ACAD is still an independent company when sales hit $1 billion within 18-24 months(if that long) then the buyout price will be TRIPLE what it is today-----near $100. And that is NOT factoring in the ADP business or approval for that indication which will be coming.

    Sentiment: Strong Buy

  • Reply to

    2016 Price Target

    by crecy_war_knight Apr 30, 2016 1:45 PM
    mgm2020 mgm2020 Apr 30, 2016 2:28 PM Flag

    I think that a lot of analysts were holding back due to the possibility of a MUCH stronger warning----and all Nuplazid got was a generic warning about elderly with dementia. Nothing at all specific to the drug or PDP! That should remove any doubt as to how large a percentage of PDP patients will be treated with Nuplazid-----it should very quickly rise to 50-75% and higher. And there will be off-label prescribing. This drug SHOULD be presented to anyone suffering from Alzheimer's psychosis as well as their families/caregivers as an option. The first new one(and one of the safest) to come along in a while. Price targets aside-----ACAD should end the year MUCH higher----if it is still an independent company.

    Sentiment: Strong Buy

  • mgm2020 mgm2020 Apr 30, 2016 1:27 PM Flag

    Absolutely correct. None of the antipsychotics currently being used by MD's for PDP are "approved" for that, and they ALL carry more severe warnings than Nuplazid will, and that hasn't stopped them from Rx'ing it off-label for PDP. The same will go for Alzheimer's agitation and psychosis with many doctors deciding to give it a try for their patients since it has a very good safety profile and does not affect motor function---which is important to anyone on this drug. Nuplazid COULD become the drug of choice for Alheimer's psychosis even without that specific approval-----yet. It happens all the time in medicine. Lots of treatment crossover. If something turns out to be better than the current standard of care, physicians tend to figure that out pretty quickly on their own.

    Sentiment: Strong Buy

  • Reply to

    Here's the BBox

    by crecy_war_knight Apr 29, 2016 7:33 PM
    mgm2020 mgm2020 Apr 30, 2016 12:28 PM Flag

    Totally generic and says nothing specifically about Nuplazid or PDP and increased risk-----only about the ELDERLY with dementia and increased risk taking ANY antipsychotic medication. But nothing at all negative about treating PDP with Nuplazid-----NOTHING!

    Sentiment: Strong Buy

  • Here is a copy of the label and the "warning" as shown in the press release:
    "Important Safety Information and Indication for NUPLAZID (pimavanserin) tablets
    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
    Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis. "

    THAT IS NOTHING!! That still leaves the door WIDE open for doctors to prescribe off-label for other psychosis if they chose(if it will help the patient in their best judgement they have every right under their license to prescribe any drug for any purpose). This is absolutely the BEST POSSIBLE SCENARIO for the approval and label. Only a cautionary warning of the increased risk of mortality with ELDERLY patients treated with Nuplazid------DUH!!! I believe the elderly are at a higher risk of mortality when they're treated with anything. And the launch is planned for June----much quicker than with other brand new drugs thanks to the hiring of the sales force already and the pre-approval publicity and knowledge of Nuplazid. THIS WILL ROCKET OUT OF THE GATE!! For ACAD and shareholders this could not have worked out any better. This is a double rarity-----a NEW DRUG that has NO FDA APPROVED COMPETITION and a tremendous unmet medical need, and a label that includes a very generic warning when every other unapproved drug that has been tried to treat PDP(that doesn't even work and worsens motor symptoms) carries one!! This will not only be the first choice for ALL DOCTORS treating patients with PDP(and even ADP)-----but it will be the ONLY CHOICE!!! Buy at the open and hold through the buyout!

    Sentiment: Strong Buy

  • mgm2020 mgm2020 Apr 30, 2016 11:11 AM Flag

    Funny how this article was put out this morning---long after the approval was issued. But previously the author had put out articles naming Acadia as one of a few stocks where investors could DOUBLE their money.

    Sentiment: Strong Buy

  • mgm2020 mgm2020 Apr 30, 2016 11:05 AM Flag

    Why would $39 be considered bashing? He explained previously how he calculated that the options spread was equal at a price $6 higher or lower than the stock price so that is what he is basing his prediction on. I think you can throw that out the window due to the short position-----which does NOT want to be locked in if there is a rapid buyout offer----and the fact that I do NOT think that approval was "priced in" at all due to the uncertainty of ANYTHING that the FDA does and the history of the development and length of time to approval for Nuplazid. Now I suppose that shorts don't HAVE to cover and they can leave their position in place for as long as they want(unless they get a margin call), but it sure makes sense to cover their position now rather than at $60 or $70 or higher.

    Sentiment: Strong Buy

  • the risk of increased mortality in elderly patients. The Reuter's article says that the FDA has "asked" ACAD for a "black box" warning, and the AP article simply says that Nuplazid will come with a "warning" but no black box. Which is it---and does it even matter? I say no, since all other drugs used to treat PDP--which are NOT approved for that carry "black box warnings" and Nuplazid is safer and more effective than any of them. But there is certainly a difference between the FDA "requiring" a black box label and "asking" for one. I didn't think the FDA "asked" for anything----just demanded.

    Sentiment: Strong Buy

  • just asking. Hopefully jumped off a bridge somewhere.

    Sentiment: Strong Buy

  • mgm2020 mgm2020 Apr 30, 2016 10:34 AM Flag

    The company would never accept that low a price. The stock reached that price a few months ago. The MINIMUM for a buyout would be $75-$80. And in 2 years that price could be up to $100-$120.

    Sentiment: Strong Buy

  • mgm2020 mgm2020 Apr 30, 2016 10:29 AM Flag

    Thanks to the increased short position, likely as a hedge against a negative outcome, and the label being about as good as possible------I say the stock SOARS and hit's $45 before pulling back. EVERYONE knows that ACAD is now the ripest bio/phama stock for a buyout with a drug that has NO APPROVED COMPETITION, 20 year exclusivity-----AND other applications coming that will increase the value of Nuplazid by 5-10 fold!

    Sentiment: Strong Buy

  • Reply to

    Compensation Levels

    by a911stockman911 Apr 29, 2016 10:11 AM
    mgm2020 mgm2020 Apr 29, 2016 10:55 AM Flag

    There is much more incentive that way to increase the price of the stock. Isn't that what we want?

    Sentiment: Strong Buy

  • Reply to

    IMO 8400 - DLBCL trial

    by soup2222 Apr 29, 2016 6:40 AM
    mgm2020 mgm2020 Apr 29, 2016 10:53 AM Flag

    The report says that Idera "fell short of internal expectations" for 8400 in DCBCL as graded by the corporate executives, who also gave the entire category 90% as far as achieving all of the company's goals. I think the company was expecting a more rapid trial enrollment. The trial enrolled fairly slowly until the 8400 WM results were released and then Bob told me that the trial doctors were very excited by the results and enrollment was accelerating. Now they have amended the trial to include higher dosages just like WM. That is all.

    Sentiment: Strong Buy

  • presenting if he wasn't totally ready AND had nothing positive to present? I expect the ship to be righted and business to be right on track. Posard is NOT enough justification for the stock price to have dropped by over $2.50. I expect to see the stock back over $5 next week.

    Sentiment: Strong Buy

  • mgm2020 mgm2020 Apr 28, 2016 5:46 PM Flag

    Nothing wrong with that. I did the same thing. Bought a few thousand shares in the $3's and sold them around $5---around my core position, though. Still holding a large position and if the stock drops I will add a few thousand more.

    Sentiment: Strong Buy

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