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Its gotten to the point where they really need to sell the company but I have zero confidence in management having any interest in doing so. They are no longer working for investor interests but would rather keep the status quo & collect their salaries.
They don't even mention QSM in the presentation.
Are you jesting? KMART has the "Bluelight Specials". I've actually seen a flashing blue light in the stores.
Explanation: Blue light Special - The sales are so good they won't be around long.
Adam retracted his comment but I imagine he was a little early & another negative headline will hit the sector in the coming days. We've got the congressional hearing on drug pricing so I think the blue light specials will become going out of business sales in the coming weeks.
Adam Feuerstein is hinting at another biotech blowup after the bell or tomorrow. I'd wait on doing any buying.
"Really sorry to see how successful Citron has become." I think your directing your disappointment at the wrong parties. The problem is with pharma at all levels. Citron's exposed the most abusive pricing practices but if you look at the price increases throughout the sector then something has to change. Pharma & biotech shareprices got hit when investors got scared the dirty little secret was about to be exposed.
A lot of companies are doing ground breaking work & investors need to be rewarded but how can Mylan justify an average 25% increase in their generic drug pricing last year? Just look at the history of a drug like Copaxone. $16000 in 2005, $42,300 in 2012, $60,500 in 2014.
There are countless examples of unsustainable drug price increases. It can't last forever.
If I was a shareholder of IMMY then I'd want the CEO to explain why they're willing to sell the drug for $1 per pill. Why not sell it for $5 or $10 a pill? When the competition asks $750 per pill then $1 a pill seems like a ridiculous price.
ONCE - Pick your reason for the selloff, reimbursement questions, market size, how long the visual improvement will last, failed one of the secondary endpoints (visual acuity - ability to read letters).
The company mentions one boy in an earlier study who could play baseball after his treatments & read. Investors believed the treatments were a cure for blindness but its not quite that dramatic. If you've watched the earlier videos then being able to navigate the maze is a huge improvement but it may take time for investors to appreciate the significance.
I think its a buy at these levels but it wouldn't surprise me to see it trade another $5 lower.
OT- Whogo70
I've changed my yahoo account to Gaspasser200.
My email is Gaspasser200@yahoo.com.
You can click on my profile to see I've had this account for a long time.
OT- Before I complain to Investor Hub I wanted to see if its a problem on my end or I-Hub. I'm having more & more problems accessing Investors Hub & I think its due to the loading of advertising. I'd rather pay a few bucks more & have a website that works. Its gotten very frustrating. Are other subscribers having the same problem with the website not-responding or very slow loading pages.
POSTING LOKO's speculative drugs in case he deletes it over on the Yahoo board.
speculative drugs of choice will cause the price to rise to fast
.
....Certainly there can be no discussions on my speculative, but high probability, drugs of choice, which to remind everyone, the Speculative PRs we're waiting for are ....:
1) Neutroval... any day now...
2) Follitropin... any day now
3) Interferon... any day now....
4) DiaPep277... later this fall...
5) Copaxone... Later this fall...
6) NxTra.... any day now....
7) MTX .... any day now.... and with whom, shall I speculate?
8) Balugrastim... later this fall... along with its cousin.. XM22 -- Alazima and Lonquex... respectively......
9) Nestorone ... not nastyGel.... some time in our life time.....
JUST SO YOU KNOW, DO NOT DISCUSS ANY OF THOSE DRUGS LISTED... IT WILL UPSET THE BALANCE OF POWER
Its a little surprising that the stock has not performed better after ACOR's acquisition of Civitas. I tend to think the warrant holders are the problem with the stock.
I will not continue this conversation but I will provide the most recent information since you've elected to pick & choose.
- There are no differences in patient outcomes when anesthesia services are provided by Certified Registered Nurse Anesthetists (CRNAs), physician anesthesiologists, or CRNAs supervised by physicians, according to the results of a new national study conducted by RTI International. The study, titled “No Harm Found When Nurse Anesthetists Work Without Supervision by Physicians,” appears in the August issue of Health Affairs.
The RTI study examined nearly 500,000 individual cases and confirms what previous studies have shown: CRNAs provide safe, high-quality care. The study also shows the quality of care administered is equal regardless of supervision.
I love the way your disparaging CRNA's. In general most CRNA's do not need supervision. I won't argue on this board but I hope to never work in the same facility as you.
Suggamadex - I'm a nurse anesthetist & don't think Suggamadex should be approved. There is no doubt the drug causes a hypersensitivity reaction in some individuals. I read a post saying there is no alternative which is incorrect. The life saving measure is to support the patients breathing or reintubate an individual if they have residual paralysis.
Atracurium was approved in 1997 & was a great intermediate-duration non-depolarizing neuromuscular blocking agent unless you had a hypersensitivity reaction. It was removed from the market in 2001 after a few individuals died from bronchospasm. I think the same thing would happen with Suggamadex.
Suggamadex will never be widely used so I'm surprised MRK doesn't give up on approval.
MEIP - there is a disconnect between the valuation & the clinical data. The only thing that makes sense is that investors are not interested in HDAC inhibitors but that will change with positive results.
KYTH - they show some impressive improvements in their investor presentation. I bought the stock as soon as I saw the slides.
http://files.shareholder.com/downloads/AMDA-MFNLA/3902436945x0x802673/8E199CD4-3F95-408C-98A6-D7BF951CEB2F/KYTHERA%20IR%20Deck_1.12.15_FINAL.pdf
Loko, posted this on yahoo.
lokodaug • 23 minutes ago
Mylan’s EpiPen Defense Against Generics Focuses On Device Design
By Brenda Sandburg / Email the Author / View Full Issue
Executive Summary
"Mylan wants Teva to conduct comparative studies of its epinephrine auto-injector and to resubmit its ANDA as a 505(b)(2) NDA; citizen petition includes declaration from former FDA advisory committee member."
The company should just close shop. The bad news never ends.
CANF - $3.785 up 8% today. Small float & market cap. Psorasis data in the 1st qtr
CYNAF - Jason Napodano has done a good job of explaining why apomorphine is a better therapeutic approach in treating off episodes then levodopa. Its going to take years before we'll know if Acorda overpaid but I have a hard time believing the inhaler will capture a larger market share then CYNAF's strip. If I was ACAD then I'd buy them out right now.
I also think the inhaler is a bad choice for this patient population. Your already talking about a group of patients will poor respiratory function so why introduce a foreign substance?
POZN - trading at $8.41. Nice recovery so far.
Ask him when was the last time management had a meeting with the FDA? They originally had an agreement with the FDA concerning the bioequivalence parameters of SQ vs sublingual apomorphine. The bioequivalence studies showed that CYNAF's formulation was outside those agreed upon parameters so was a meeting conducted to discuss the differences before proceeding to the Phase II & III trials?
What type of FDA communications are normally held for a 505(b)(2) filing? Do they intend on having a meeting before filing the approval application?
POZN - Jason Napodano has a blog on the breakup. He views it as a positive. http://bionapcfa.blogspot.com/2014/12/pozen-seeking-new-partner-for-yosprala.html
POZN - I understand selling since you can always buy back once you understand how the market will react but I don't think you can read anything into SNY dropping the partnership. I imagine POZN will find another partner once PA gains approval & the label is known.
FLML - The FDA allowed unapproved generic neostigmine into the US from APP & West Ward pharmaceuticals when there was a shortage. FLML has the only approved version of neostigmine (Bloxiverz). Once the shortage was resolved & FLML proved they could supply the entire market the FDA asked that the generic suppliers quit importing supply which was about 6 months ago but they allowed the manufactures to sell their inventory.
My hospital is still stocked with generic supply so did they stuff the channel & how long until this inventory is worked off? FLML is saying distributors are no longer shipping the generic but I'm not convinced.
If FLML has 100% market share then its a $250 million plus market for them but the problem is how long until a generic is approved. FLML has admitted they have no protection against a generic supplier except the 3 yr approval process but no one knows if or when an ANDA was filed.
If your lucky then FLML might have 2 plus yrs to control the market but its going to be an ugly surprise to shareholders when a generic gains approval.
FLML management was supposedly making the rounds last week with institutional investors so I guess they found a few buyers. I can easily see the stock going to $20 next year if they gain 100% of the market.
Congress Investigating Why Generic Drug Prices Are Skyrocketing
Thursday, October 2, 2014
BURLINGTON, Vt., Oct. 2 – U.S. Sen. Bernie Sanders (I-Vt.) and U.S. Rep. Elijah E. Cummings (D-Md.) today launched an investigation into soaring generic drug prices.
“We are conducting an investigation into the recent staggering price increases for generic drugs used to treat everything from common medical conditions to life-threatening illnesses,” Sanders, chairman of a Senate health care subcommittee, and Cummings, ranking member of the House oversight committee, wrote in letters to 14 pharmaceutical companies.
They pointed, for example, to the price hike for Albuterol Sulfate used to treat asthma and other lung conditions. The average cost for a bottle of 100 pills was $11 last October. The average charge by this April had shot up to $434. An antibiotic, Doxycycline Hyclate, cost $20 last October for a bottle of 500 tablets. By April, the price was $1,849.
The price data on those and other generic drugs came from the private Washington, D.C.-based Healthcare Supply Chain Association. It surveyed average prices paid by organizations that help hospitals, nursing homes and home health agencies negotiate with pharmaceutical companies and other vendors for discounts. The figures are akin to wholesale prices, not the amount patients are charged.
Cummings and Sanders cited a survey that found pharmacists across the country “have seen huge upswings in generic drug prices that are hurting patients” and having a “very significant” impact on pharmacists’ ability to continue serving patients. The study for the National Community Pharmacists Association also found some patients refused to fill needed prescriptions because of rising prices.
“It is unacceptable that Americans pay, by far, the highest prices in the world for prescription drugs. Generic drugs were meant to help make medications affordable for the millions of Americans who rely on prescriptions to manage their health needs. We’ve got to get to the bottom of these enormous price increases,” Sanders said.
“When you see how much the prices of these drugs have increased just over the past year, it’s staggering, and we want to know why,” said Cummings. “I am very pleased that Chairman Sanders has joined me in this bicameral investigation because in some cases these outrageous price hikes are preventing patients from getting the drugs they need.”
To read a fact sheet, click here.
To read the letters, click the links below:
Actavis plc
Apotex Corp.
Dr. Reddy’s Laboratories Ltd.
Endo International plc
Global Pharmaceuticals
Heritage Pharmaceuticals Inc.
Lannett Company, Inc.
Marathon Pharmaceuticals, LLC
Mylan Inc.
PAR Pharmaceutical Companies Inc.
Sun Pharmaceutical Industries, Inc.
Teva Pharmaceutical Industries Ltd.
West-Ward Pharmaceutical Corp.
Zydus Pharmaceuticals USA Inc.
Click the link below for the letters, interesting price increases
http://www.sanders.senate.gov/newsroom/press-releases/congress-investigating-why-generic-drug-prices-are-skyrocketing
Cacheflash, I think its better to use the lower range until proven wrong when estimating the current run rate. I'd use the 4 week script avg & forget the possibility that scripts are averaging more then 30 days. No discounts or LEO sales are being used so your overestimating the revenues.
When management gave the Otrexup sales numbers needed to achieve breakeven then I guarantee it wasn't a gross number.
Cacheflash, sometimes I only post a portion of a story, topic, etc. since that's the best way to get a reaction out of posters. It may cause them to do some of their own investigating. It has nothing to do with misleading.
Whogo
I did an advanced search & it only lets me see the first page of results. Has anyone else had this problem. There is no link to click on next page .
Why would Adam turn down an offer to discuss the data? Isn't that what he does for a living? It makes no sense to me. He should have tweeted out his reason for declining since it wouldn't have prevented him writing a negative article once the briefing notes were released.
So are you trying to say the thumb is not needed to use the Otrexup injector? Maybe you need to look at the Otrexup user guide.
For the last 2 plus years I've stated ATRS would have difficulty signing a partnership in the EU due to lower priced competition.
Are you trying to say Medac didn't conduct user studies for their device?
Are you trying to say Beckinson Dickinson manufactures some Micky Mouse device in comparison to ATRS?
I'm just saying the need for an injector is overstated. If a person can use ATRS or Medac's injector then they could use a basic pre-filled syringe.
Before you say I'm wrong look at the steps needed to use Otrexup.
From the last PR on QST
"Approximately 150 patients will be enrolled in this study. Patients meeting all eligibility criteria will be assigned to receive a starting dose of QS T once weekly for six weeks. Adjustments to dose may be made at week seven based upon the week six pre-dose blood level. The efficacy of QS T and dose adjustment to regulate testosterone levels will be evaluated after 12 weeks of treatment. Upon completion of this phase, patients may remain on their optimized QS T dose and will be followed for an additional 40 weeks. Approximately 100 patients will be needed to complete collection of 26 weeks of safety data, and approximately 50 patients will be needed to complete collection of 52 weeks of safety data"
Evaluated at 12 weeks
Followed for an additional 40 weeks
40 + 12 = 1 yr
My biggest question is the cost for the QST clinical trials. They originally said it was going to be similar to the cost for Otrexup's development which was less then $20 million but I'm not sure they anticipated a year long trial for QST.
I think SQ midazolam is a better choice then diazepam for the treatment of seizures. If you do a quick search I think you'll find midazolam as the preferrred anti-seizure med for children & adults. I believe nasal versed is carried on ambulances for the treatment of seizures.
We've had this discussion before & some posters thought SQ midazolam was to dangerous (black box concerning respiratory depression) but studies don't show that to be true. I use it everyday of kids & adults with no problems.
"SQ MTX market exclusivity"
A company could potentially have filed for ANDA approval of a basic pre-filled MTX syringe without investors being aware. The company has always said this was not a competitive threat.
"Does anybody know where Teva is at in the process of gaining FDA approval for their generic epipen"
Under the Generic Drug User Fee Amendments of 2012, the FDA is now directed to take patent expiration, blocking exclusivities, etc. into account when prioritizing work on ANDA reviews.
Don't expect approval prior to the agreed upon June/2015 date.
The only thing I strongly believe in is that TEVA should buy-out the company within the next 12 months for $4 a share. I think everyone would be happy.
The board of directors won't accept a takeover attempt if its just some sort of low ball offer. If the board votes to approve a takeover at $2 then that's probably all the company is worth even if investors are not happy. The company also has to obtain a majority of shareholder votes to approve the takeover.
The company never projected breakeven in the 4th qtr & the $200 - $300 million peak sales numbers are just estimates. Posters on the yahoo message board are the only ones projecting 4th qtr breakeven. The company hired an outside firm to survey rheumatologists & potential sales were extrapolated from those opinions. Most of these projections turn out to be wildly over optimistic for any number of reasons.
I know as much or as little as any retail ATRS investor & I have no idea how to value the company. Investors always think their investments are worth more but an opinion won't get you very far.
If Otrexup sales continue to increase then the company is undervalued but if they never achieve the breakeven level then the companies probably fairly valued at this point.
Funds are required to transmit holding on a semi-annual basis within 70 days of the qtr ending. Some funds do this on a qtrly basis.
Nothing much, Wotten left for a penny scam stock & another company got approved to market a competing methotrexate injector. Besides that its business as usual.
Yellen also said all small biotechs are overvalued.
"My goodness how low can this go"
I think more & more people are wondering if its a broken business model. Management has to reverse that way of thinking.
That's because its understood that we're all morons for wasting so much time on the stock instead of investing that time on other opportunities.