Could it be, maybe, that Omontys, is just bad medicine? The "inexplicable" results of the EMERALD/PEARL clinical trials resulted in the anomaly that O was statistically significantly more morbid/deadly compared to industry standard ESAs for the healthier CKD patients not on dialysis but was not inferior to industry standard ESAs for the sicker CKD patients who were on dialysis. Don't foreget that the EMA did not approve O for the European Union because O's benefits did not outweigh its risks and the clinical data Takeda submitted in support of O might not be reliable.
You are nothing buy sour grapes longfellowsss. If anybody wanted to conspire in this market it was you who hoped to organize a short squeeze. Go look in the mirror for the reason you lost your investment in AFFY.
I consistently told the truth about O and AFFY and my posts invariably got the most thumbs down of any on this board. Grey and I spoon fed all who could read about the horror story of O with cites and quotes, but the incessant longs, high on Maxdad weed and drinking EXP Kool-Aid, could read but not comprehend. I am sorry for them if they did not sell when they had the chance.
AFFY disclosed some time ago that neither AFFY nor Takeda are paying the fees necessary to keep the O patents current. Based on that disclosure and Takeda's write off of its $45.8M interest in O to $0, I believe AFFY's patents for O aren't worth hardly a plug nickel. And don't forget, whoever buys AFFY (instead of its assets) also gets AFFY's litigation exposure.
In its Sep 2013 annual report Takeda disclosed that it written down to zero value its entire interest in O. What does that tell you? It told me to stay short AFFY, and Takeda's write down of the full value of Omontys patent to zero confirmed that Takeda did not intend to reintroduce Omontys into any market. If any sales revenues whatsoever were ever expected, does it make sense for Takeda to write down the value of the O patent to $0?
At page 117 of its 2013 Annual Report, Takeda discloses as follows:
As a result of the significant decline in profitability of patent rights and sales rights, their respective book values were written down to recoverable amounts, and the decrease was recognized as impairment loss....
As described in the note of "Loss on voluntary recall of products," based on the decision to voluntarily recall a product at the Company's US subsidiary had sold, the Company recognized impairment loss on patent rights of Y4,294 million ($45,681 thousand) expected to have a recoverable amount of zero. This impairment loss is included in "Loss on voluntary recall of products."
Loss on voluntary recall of products
The Company decided to voluntarily recall a product that the Company's U.S. subsidiary had soled due to the unfavorable outcome from the post-marketing surveillance performed. The losses are impairment loss for patent rights associated with this voluntarily [sic] recall and other losses attributed to the Company and the U.S. subsidiary based on the arrangement with the in-licensing partner company.....
Had to say it. Their 4 successive AFFY pumps and dumps allowed me to get increase my AFFY short position. But I had to take a brow beating from them and this board to do it.
Once again, Greycorner and I have been proven correct. Grey, like me, always explained that Takeda and AFFY knew there was problem with O's safety, which, at core, is why O was never approved as an ESA for CKD patients generally, but paradoxically only for the "sicker" CKD dialysis patients. Time and time again I pointed out the "inexplicable" mortality/morbidity rates between the PEARL and EMERALD studies. There is still no answer, and AFFY's only avenue to evade the strict products liability claims is BK. But BK won't happen until Orwin and The Brenner Group have nothing remaining to pay themselves with.
Class action settled. Of course it did, AFFY is bankrupt except for the insurance policy proceeds. Any lawyer worth his salt understands that writing on the wall. Why waste time and money going after anything other than the insurance policy. If AFFY had any other assets the class action would not have settled. IMHO after having practice law for over 30 years. Looks like the products liability litigation will be the stake in the AFFY heart leading to BK. The Honorable Orwin-san and others, including The Brenner Group, apparently still have some cash left so they can keep paying themselves in their sinecure. I am not ashamed. I warned everyone time and again and was only castigated for speaking the truth.
The Massachusetts State Ethics Commission cleared biopharmaceuticals company CytRx Corp. Friday from a preliminary conflict of interest inquiry regarding a consultant's simultaneous work for the company and a Massachusetts university.
The consultant, Ruvane E. "Rip" Grossman, has been fined $10,000 by the commission for bringing the University of Massachusetts Medical School and Los Angeles-based CytRx (NASDAQ: CYTR) together to discuss marketing a potential new drug therapy. He also took part in negotiations of a licensing agreement between both parties.
But at the same time, Grossman had a consulting contract with both sides.
Just sums up what I have been posting quite some time now. AFFY longs will probably grasp at the NOLs, as did Maxdad, to suggest that the $138B NOLs are worth something. As a retired lawyer who knows something about tax law, the NOLs are not available to new shareholders as a result of a buyout. My prior posts explained why, and Maxdad just flat out lied about it being otherwise. Interesting that Maxdad is no longer around after he and EXP teamed up for 4 successful AFFY pumps and dumps. I agree with Propthink that AFFY is not even worth 66 cents a share.
Bearing in mind the Actos $6Billion puntive damage award against Takeda, the answer is a resounding NO. In fact, Takeda has decided not to pay the monies necessary to protect the Omontys patents. Does Omontys sound like a blockbuster ESA compared to industry standard medicines such as Amgen's Epogen/Procrit and Roche's Mircera (dosed once every 4 weeks) with proven safety profiles? All of the other ESAs are approved for anemia in all patients, not just the to the sicker CKD dialysis patients that the FDA limits Omontys. Why is that? Paradoxically, the Omontys clinical studies (open label) showed that Omontys was unsafe to treat anemia for chronic kidney disease patients generally, but was safe to administer to the sicker chronic kidney disease patients who were on dialysis. Doesn't make any logical sense does it? AFFY and the FDA agreed that those paradoxical safety findings were "inexplicable" and for which "there was no definitive answer." Are there better biotech investments available? You be the judge. But for me, AFFY has little alternative but to go bankrupt. Failed drug. Proven alternative ESAs. No remaining business other than winding up affairs. Shell corporation. Little cash. Massive litigation. Insider selling. Time running out.
A blatant falsehood which is par for the course for AFFY longs. Here is a truthful excerpt from a Seeking Alpha article that reported on the FDA adverse event data base:
"The data shows there have been 22 deaths in which Omontys was reported to be the most likely cause of death! Furthermore, the report shows there has been at least one death (multiple additional cases of adverse events) reported as a result of subcutaneous administration of Omontys. Ex-CEO, John Orwin previously said "there have been no reports of such reactions …in patients receiving the drugs subcutaneously-although the subcutaneous patient numbers are limited". A key underpinning of the AFFY bull case was that the drug could be reintroduced under a limited subcutaneous-only label. That optimism appears misplaced now given a subcutaneous death. The FDA data presented here renders Orwin's statement patently false. We believe it is extremely unlikely that the FDA approves an interim reintroduction of Omontys under a subcutaneous label."
Yep. Takeda needs to ignore the many ESAs with proven safety profiles that do not require any of these extraordinary measures as you suggest. In the meantime, Takeda has decided to let Omontys patent protection lapse because it does not want to spend the funds to renew the patents. Sounds like a winner to me.
Either a Chap 11 reorganization or a Chap 7 liquidation will enable AFFY to purge itself of the litigation. It will be interesting to see if AFFY goes Chap 11, which can later be converted to Chap 7 if no likelihood of reorganization, or Chap 7 as the first filing; The problem for AFFY is that a Chap 11 is predicated on some sort of surviving business enterprise, which is difficult to project without the possibility/likelihood of O being reintroduced to market before the cash runs out. Unless O can be reasonably expected to return, then Chap 1 liquidation appears more likely.
Interestingly Grey, the Takeda/AFFY decision not to protect O's patents must lessen whatever worth AFFY's intellectual property (already impaired by the grant of the exclusive WW license to Takeda) would otherwise be expected to fetch on the open market via bankruptcy sale.
In either a Chap 11 or a Chap 7, it is the AFFY shareholders who are last in line to recover monies. I have not practiced bankruptcy reorganization for many years. All I can say is that IMHO, and if one assumes that O is just bad medicine and cannot return to market given that there exist several ESAs with proven safety profiles, then AFFY shares will ultimately become worthless such that I would not buy shares even at 20 cents. But who knows. Maybe Orwin-san can pull some kind of rabbit out of the AFFY rat hole.
You got a Takeda update through AFFY's recent 2013 10K. Neither Takeda nor AFFY are enforcing the Omontys patents. What does that mean? Can you "read between the lines", so to speak, in this instance? Probably not, so I will tell you exactly what it means. Instead of being a blockbuster drug, Omontys is not even worth the cost of patent protection. Maybe market manipulation will enable you to sell so it is not a total loss for you. IMHO AFFY bankruptcy appears inevitable as it has for quite some time now.
From AFFY's 10K: Throughout the course of the year, Takeda has elected to limit or terminate the continued prosecution of the various U.S. and international patents covering OMONTYS, including those covering most of the European countries. We have elected, as is our right under the Agreement, not to continue prosecution of those patents when Takeda has determined to terminate its prosecution rights for such patents. Accordingly, we or Takeda will likely not be able to maintain patent protection for OMONTYS in any country, including the U.S., should the product be reintroduced into the market.
AFFY longs can read, but due to smoking Maxdad weed and drinking EXP Kool-aid, they do not comprehend. Fortunately, I was even able to read between the lines of the Fresenius letter and short AFFY at $15 plus pps, cover, reshort more, cover again and then short again. I am still short AFFY awaiting its inevitable BK and LT cap gains. What makes one think that AFFY is even worth 70 cents pps? MM manipulation? Fundamentals? Recalled drug. No "root cause" determination. Massive litigation - both class action securities fraud and products liability claims. No disclosure of adequate insurance coverage for litigation liability. No business other than winding up affairs. Little cash. Time running out..
In first year law school civil procedure class, Professor Meador used to say about the American/English law of precedent, "Win one. Win one. Lose one. Lose them all." Now Takeda can look forward to losing then all, at least with respect to Actos and insofar Takeda fails on appeal to get the decision reversed.
Consider this jury verdict AFFY longs. Do you still believe Takeda will rescue Affymax by persuading the FDA to allow it to reintroduce Omontys to treat CKD dialysis patients for anemia so they can switch from Amgen's industry standard Epogren/Procrit (with proven safety profiles) and Roche's Mircera? Count the recent nails in AFFY's coffin. Newly disclosed products liability claim filed against AFFY and Takeda for Takeda. This Louisiana $6B punitive damage claim against Takeda. The last nail for you longs is AFFY bankruptcy.
I have been patient with my short AFFY position. With AFFY's bankruptcy at last imminent, I will be able to finally realize significant LT cap gains. There is still room for AFFY to fall.....
I am astonished the AF tweet about CYTR not being able to dodge an SEC investigation gets so much press. AF even guilds the lilly with an ominous "tick tock". If the SEC did not investigate it would not be doing its job. SEC staff lives for this kind of thing. But the more important question remains what will be the result of any SEC investigation into SEC and the Dream Team Group. Assuming, for arguments sake only, that CYTR has something to hide about its relationship/instructions to DTG and the authors who failed to disclose compensation, then at worst there will be a settlement where CYTR neither admits nor denies wrongdoing, enters a consent decree and perhaps pays a fine. Then perhaps CYTR can continue to develop Aldoxorubicin to help cancer patients and make money for shareholders. I have bought at these prices courtesy of the short attacks.