For those that follow this board they know that I posted my point of view here a few days after O was pulled and only after giving it much thought and looking at everything I could put my hands on.
This is my second note here. As I had mentioned before it is clear to me, and any experienced person in the medical field, that O as manufactured for the first 25000 patients and first 11 months of use is in NO WAY responsible for those reactions and deaths.
Put another way, you SIMPLY CAN'T NOT HAVE A MEDICATION THAT IS WORKED FOR SO MANY (25000) AND OVER SUCH A PROTRACTED TIME (11 MONTHS) SUDDENLY CAUSE ALL THOSE ALLERGIC REACTIONS.
THAT IS SIMPLY NOT THE WAY MEDICATIONS WORK.
Like I had mentioned something else much of gone wrong but that the original O and as it was originally manufactured is FINE and I feel today's stock move VINDICATES that VERY OBVIOUS point of view.
As it stands the only question at this time is when (and NOT whether) O will return to market and how long before pps returns to previous levels. MY view is that because of what mentioned above I would expect O to return to market within weeks if not days and pps will return to previous levels in short order. I actually think pps will surpass previous highs for simple reason that many doctors have become more familiar with O because of what is happened and once they know FDA is okeyed it back to market many will get on the band wagon of using it.
Sentiment: Strong Buy
You don't have to be a genius to understand the news will not be good. They are doing an investigation on their drug, which by the way, will take months. Looking at their balance sheet and what effect this this recall will have, puts it at risk. I think long term, they will get their drug back on the market, but the damage is done and providers will think twice about prescribing this medicine. In the meantime, while they wait to get back and FDA approved again, other companies they have similar drugs, will come to light. I see the stock going lower after Thursday and which point I will start my entry.
Here is why:
1. All the mentioning of BK is just to cover their as.. and to discourage the Ambulance chasers and thugs from filing further litigations.
2. Cost of running company's operations is cut to the bone by terminating all the full-time employees and hiring Benner's hourly employees to run as a shell company. This shows they will still be in business until OMONTYS is re-introduce to the market.
3. Restructuring firm is hired not to help them file BK but to help them negotiate their outstanding commitments and liabilities. Why in the world a company filing for BK will think about taking care of liabilities and reducing the deficit.
4. $46 M in cash as of March 31, 2013. They have lot of cash to survive with all these liabilities for over a longer period of time.
5. Hedge funds are constantly bashing and trying to get the shares from weak hands.But stock is moving back from $0.62 to the current levels. Lots of day trading and short covering is in effect. Big institutions are still holding their shares.
I have more reasons to believe what I said in the subject line but I will stop here for now.
Omontys injection probably caused anaphylaxis in the patients that died. This type of hypersensitivity reaction can be prevented by skin testing patients or injecting a very small quantity prior to full dose administration. Also patients likely can be desensitized to the drug using protocols similar to what immunologist use for patients with severe penicillin allergies. Also, coadministration with steroids might prevent the problem. Either way, there's alot more clinical use for this drug than shorts such as Adam Fakestein will have you believe. 99.8% of patients have no issues with this drug. It was recalled to further study the cause and to prevent the 0.2% who it adversely affects.
of Patients having an adverse reaction and it gets pulled???? Fishy!!!! The once a month treatment blows the competitors away which will lead to a 98% Market Share. I would really love to examine the deceased patients medical charts to see what pre-existing medical conditions they had prior to taking Omontys. Feel badly for their families but the Administering Doctors should have taken action to reverse the allergic reaction within the first 30 minutes as "Omontys Published warnings" told them to do????? Where are the Lawsuits against the Doctors/Staffs and the Administering Facilities??? If I am one of the family members I would start with the Doctors not the drug, negligence is easier to prove???? F....I.....S....H...Y!!!!!
the drug, the Facilities and procedures. This explains why all problems occurred at one physical location. ??
First off, this is exactly we have here today, let me start by saying Affy's Insurance will cover the "average settlement" for cases such as these which is $1 million dollars "Out of Court" payment so the Attorneys can F.O. and die!!
Secondly the Lawyers have no Case, Affy didn't report what within what time frame to whom according to what Law????? Affy did report the allergic reactions to the FDA as they occurred, then pulled the drug off the Market with a 100% Recall, thus avoided being Negligent and potentially voiding their Insurance Coverage
Thirdly the Lawsuits are full of factual errors and typos which demonstrates lack of seriousness on the part of the Litigators and proves they seek an Out of Court "Pay Off", also the dozen or so Lawsuits are repetitive in nature and will be thrown out or consolidated into one Lawsuit.
Fourthly, look at any Drug Stock that has bad results in Phase III, or after FDA Approval resulting in a dramatic drop in the PPS and guess what??? Blood sucking Attorneys come out of no where seeking Shareholders to start a Class Action Lawsuit because the CEO and BOD "hid something" from Investors! It is less expensive to Settle out of Court than to fight them in Court so the Insurance Co. doles out $1M.
Finally, and sorry for writing so much, but I am fed up with all the lies posted here to scare people regarding Affy Lawsuits (by the way it took months for them to find one lead Plantiff, Lol) so I view Lawsuits and the resulting supposed BK as being a dead issue and of little concern to Affy's Board of Directors. (BOD) or to me!
An example to end on, one Drug Stock I owned was accused of "hiding CANCER" as a result of taking their drug and the stock crashed big time, guess what? Attorneys showed and sued, long story short, they got $1M in a Out of Court Settlement and the stock rebounded 900%!!!! Geeesh!
I’d like to preface my comments by disclosing that I’m longer than a horse here. That said and all biases aside:
For those of you who assumed that the opportunity/binary play was related to Fresenius and “will they or won’t they,” and that the worst case was a $10 pps if the latter came to fruition, your head must be spinning today. The truth is that the announcement of 19 anaphylactic events and 3 related deaths was unrelated to Fresenius’ evaluation. It was a meteor, a bolt of lightening or choose your analogy.
Having said that, what happened? What we know:
1) Omontys has been administered to some 27,000 patients (clinical trials and on the market once approved).
2) Omontys was administered for more than 2.5 years (again, between clinical trials and once approved and sold).
3) During those 2.5+ years, there were no such reports of extreme allergic reactions.
4) Fresenius, in their internal memo last week, which was made public, stated that Omontys was “well tolerated” in a patient population of 18,000 and that allergic reactions were infrequent and that severe allergic reactions were almost non-existent.
5) Suddenly, in February and after 32 months of no such incidents, 3 deaths occurred which were attributable to Omontys.
So, the question becomes; what happened in February that caused these sudden adverse reactions, which were not consistent with the previous 32 months? Because the deaths occurred in a short span of time, this would certainly suggest that the deaths are likely attributable to so certain circumstances that came about recently.
1) Introduction of Omontys to new centers without proper training for the administrators.
2) Supply chain issues/delays, which may have compromised a few lots of product.
3) Contamination associated with certain lots of product.
4) In symbolic observance of black history month; excessive consumption of Hennessey among Affymax minority manufacturing personnel resulting in carelessness and subsequent contamination of product.
The FDA has launched an investigation, but the truth is that we may not learn the root cause. That said; consider the statistical probability of 3 deaths in 3 weeks when zero deaths had been observed in the previous 32 months. Coincidence?
This may very well be my last post here if the stage is set for Omontys issue is partially or wholly settled by this Thursday's CC. Of course some of you have read parts I & II of this series. I do, however, want to point out the followings (some of which is repeats):
1- As previously mentioned I have been practicing medicine for a few decades and getting ready to hopefully retire in the near future. There is an old saying that there are no coincidences in medicine. Any doctor, nurse, pharmacist, etc involved in today's health care can tell you with 100% certainty that there is NO WAY IN THE WORLD that you could have over 25000 patients take any drug, by injection or otherwise, without any serious side effect and then suddenly in February, and after 11 months of usage, you have 3 deaths unless there were some new external factors introduced. Science of medicine while complicated it also involves some simple common sense facts and this is one of those facts. Omontys as manufactured prior to February could not have possibly caused those deaths. The culprit could be something went wrong on February batches or other medications were begun to be given at the same time as O beginning February that could have caused this or the culprit could be dialysis equipment malfunction or defect, or..., or...., or....BUT NOT OMONTYS AS MANUFACTURED UP UNTIL FEBRUARY AND AS USED BY THE FIRST 25000 PATIENTS.
2-Omontys was and is well regarded by many physicians as once a month dosing allowed it to be administered in the nephrologist offices as well as some internists and family physicians and did not have to be necessarily coordinated with the dialysis centers. While currently most were given by these centers the trend was to move the injection to the clinics and no doubt once O is retuned to the market that trend will continue.
3-The number of deaths....continued
These reactions could have been resolved in the same fashion as for those who are allergic to "Bee Stings", and we would be at $27.00 today and climbing to $35.00!!! Maybe this is why the stats show all the buying from weak hands is by Hedge Funds, they know AFFY is a 20 Bagger.
Any deals being made currently, and I assure you deals are being made, will have to made Public prior to that date to satisfy full Public Disclosure Requirements. Therefore the Shorts day of fun in sun is about to end suddenly, and they will have to move in with Old Fool Poo Tool!!! Lololololol
10. AFFY now has hired a restructuring firm. I wonder what they have been doing this entire time, could it be that they were restructuring, as that was the "game plan" this entire time. Yes, I believe it was their intention and they have accomplished their goals since their recall very effectively.
11. Firing a CEO who was being paid over a million a year, plus a CFO for a company that does not need to be paid was brilliant. Also pay special attention to the "company wide restructuring", their options in the past 8 K filings have been bk or another avenue such as... you guessed it restructuring in order to sell itself. Of course this is my interpretation of the language in the 8 filings.
12. I cant see the future but i am highly certain that a buyout is in the works as TAKEDA would be stupid to allow someone else to purchase the royalty agreement. An upfront payment of less that 300 million would be sufficient to buy AFFY outright and never pay a dime to anyone. In one year, they would be in the positive from the sales attributed to the sales of OMONTYS. This is the reason that in the past they did not market in JAPAN, even though they had approval but now renegotiated with AFFY for rights to market there and EU.
P.S. AFFY is still a high risk investment, please don't invest money you can't afford to lose as this can still be an all/nothing investment. I personally have invested in the company and I am long.
At this point Affymax's management and executive team (what's left of them) have the responsibility to assist in all transitional activities but no longer have financial or operational authority which is presently shared between Brenner and Takeda.
Takeda---I think everyone knows what Takeda is taking care of operationally (working the investigation into what caused the deaths at the Dialysis clinics). They are also actively involved in working through permanent arrangements to take over operational and financial responsibility of all IP presently owned with Affymax under some arrangement TBD.
Brenner--Has taken over management responsibility, working on the reorganization and transition for the ultimate disposition of Affymax's assets. NOTE: Because they are now THE management they have a fiduciary responsibility to work for the benefit of the shareholders by LAW. Because of this they can no longer legally act as an agent (deal maker, Investment Banker, etc.) because of their fiduciary responsibility to shareholders. Further, while Brenner is a highly respected reorganization firm they are NOT a law firm and only may go as far as helping to construct revised financial arrangements AS MANAGEMENT and, along with the Board of Directors, working on behalf of shareholders are legally bound to provide the maximum return to shareholders.
LAW FIRM--As of right now there does NOT appear to be a designated law firm for any bankruptcy proceedings, which further supports that such action is not imminent, though certainly possible in the future. The ONLY type of organization allowed to support an organization exercising bankruptcy proceedings are law firms. Should this occur, both Brenner and GS would be brought in by the law firm to provide testimony with Brenner representing management and GS as expert witnesses. Affymax's public accounting firm would also participate in these actions.
This is where things stand now and at this point no evidence of BK at all
It seems fairly evident from reading this board that most of the material posted is not in the least helpful and there are a significant number of bashers who run rampant like a plague. Now this is my opinion and observation and you can choose to disregard it, but here it is. OMONTYS is a once-monthly erythropoiesis-stimulating agent (ESA) for anemia primarily used in dialysis patients, most of whom have treatments MWF or Tuesday&Thursday. This drug is used to keep their hemoglobin levels up but can put them at risk for stroke or MI if their hemoglobin goes in the excess of 11g/dl (grams per deciliter). For normal healthy males the level is 14-18 g/dl, females 11-16 g/dl. The current standard of treatment is Erythropoietin (EPO), a synthetic form of the hormone that is produced mainly by the kidneys (before they were damaged). EPO shots are given quite frequently and it can take a month or two before a significant enough rise in hemoglobin/hematocrit levels ( 5%) for the patient to start feeling any better. Epogen is made by Amgen who is about to lose the patent of this inferior product, opening itself up to generic competition. OMONTYS is a significant improvement over EPO and will become the standard of care in the near future at dialysis centers across the country. OMONTYS was recalled voluntarily by AFFYMAX and its partner TAKEDA. TAKEDA (TKPHF) is an Asian based pharmaceutical company out of Japan with a market capitalization of 41.28 Billion as of April 5, 2013. The reason for OMONTYS recall was due to allergic reactions caused by the drug in 0.2% of the patient population that was administered the drug within the first 30 minutes of administration. These allergic reactions turned into full blown anaphylaxis in some of the patients and caused the death of 0.02% of 25000 plus patients that were treated by the drug. Any competent physician should know that anytime a patient is given a drug for the first time, they should be closely monitored for an allergic r
allergic reaction. If the allergic reaction does occur, the patient should be treated with a Histamine blocker such as Benadryl, a steroid such as solu Medrol or dexamethasone to reduce inflammation and Epinephrine Subcutaneous of Intramuscular depending on the severity. Also in certain situations patients may require Albuterol/ipratromium bromide nebulized treatments for shortness of breath caused by bronchospasms and IV fluids such as normal saline 0.9% to bring their systolic BP into perfusing range ( 90). So after all this mumbo jumbo, what exactly does this mean? The drug was effective in treating 99.8% of the patients. That is a significant number to keep in mind. With the recent repayment of their finance loan, reduction in workforce of 75% and continued involvement with Takeda’s management, I believe that AFFY is looking to be bought out. I personally despise the management team of AFFY but OMONTYS is valuable drug and with the right management and marketing can be a billion dollar blockbuster drug in the dialysis market. Obviously this is pure speculation on my part but with all the information available I consider it to be an educated guess. If you truly despise the company or are avert to high risk stocks, you should stay away from this company. However if you understand the fact, that a drug that cost a significant amount of capital to bring to the market and was voluntarily recalled by a company with incompetent management, then you should buy a few shares. Either way, good luck to all longs and obviously look at the quality of the subject matter of these internet posts rather than quantity to make your informed decisions on investments.
"As a result of the Amendment, Takeda assumes full responsibility for OMONTYS, including the ongoing recall and investigation of OMONTYS as well as any subsequent decisions as to whether the product may be subject to re-introduction if Takeda is able to complete the investigation and address the safety concerns to the satisfaction of the FDA. If Takeda decides to re-introduce OMONTYS, all of which is highly uncertain, the Company is eligible to receive royalties and (i) potential commercial milestone payments totaling up to $180 million of which $10 million is payable upon the first commercial sale after re-introduction of OMONTYS in the U.S., of which a $10 million and another $10 million relates to U.S. sales-based milestones, and of which $150 million relates to sales-based milestones in amounts as previously disclosed outside of the U.S. but now including Japan as a result of the Amendment and (ii) a potential development milestone payment of $5 million payable either upon regulatory approval in the E.U. or Japan. The royalties are tiered in the range of 13-17% with respect to net sales in the U.S. and in the range of 13-24% depending on the level of net sales by Takeda worldwide ex- U.S. "
In addition all investigation responsibilities and costs plus future production and distribution and marketing of Omontys goes solely to Takeda.
FOLKS FOLKS FOLKS....Don't be fooled by AH stock price. The agreement gives Affymax the best of both world. I think if not for manipulation this stock would open at $3 + tomorrow morning and be back at $15 within months of Omontys is back in the market.
And back Omontys will; I think this is quite obvious now.
Sentiment: Strong Buy
It only takes 1 test to determine if you are hypersensitive to Omontys or not. This saves at least a dozen injections a month for the patient and the dialysis center. If you do the math, it is much more convenient to administer Omontys than to give epo/procrit every time you get dialysis. Also, what about the 99.8% of patients who benefited without any side effects. I am sure they are bummed that the drug was pulled for further research. Anyways, it will be pretty easy for AFFY to demonstrate who the at risk patients are and to come up with a plan to prevent future events. This kind of stuff happens all the time in pharmaceuticals. Patients have died from taking plavix with omeprazole, so doctors don't use the same combination. Plenty of patients develop anaphylaxis from various drugs, most commonly antibiotics, but they are still used every single minute. Look, the shorts are having a field day today. It will only be a matter of time before this drug is used again with tighter control. Remember when Metformin was banned because of lactic acidosis? Well, almost every diabetic is now on it. What about thalidomide. Just saying, the medical industry will have use for a drug that they have spent $billions in developing.