1. Do not put the cart before the horse. Takeda must first satisfy the FDA that O is safe and can return to market. That depends upon the outcome of its root cause investigation which calls into question not only the O patient anaphylaxis deaths, but also the divergence in patient safety profiles between the EMERALD studies which showed O safe for CKD patients on dialysis and the PEARL studies which showed O unsafe for the healthier CKD patients not on dialysis. No one has been able to explain why that is so. It is paradoxical and does not make sense.
2. After determining the root cause, Takeda must satisfy the FDA that it has rectified O's patient safety issues such that its benefits now outweighs its risks so it can return to market. Takeda must then determine that O is still commercially viable so as to overcome its admittedly damaged reputation among the nephrologist/dialysis community who have industry standard anemia medications, Epogen/Aranesp/Procrit/Mircera, with proven patient safety profiles established over many years of use.
3. If 1 and 2 are not successfully done IN THE NEAR FUTURE, AFFY goes bankrupt. All Takeda needs to do is to let time take its course and it can buy out the Takeda $180M milestone/royalties agreement for pennies on the dollar at a bankruptcy court approved price. Takeda gets what AFFY longs say it wants - namely 100% of O - at the best price possible. A bankrupt AFFY is left to resolve its securities class action litigation and products liabilities claims. AFFY shareholders are left holding the empty AFFY bag.
One cannot avoid to give GWP some credit. He predicted 80 cents coming, and that's when pps was $1.70. It is taking a while to get there, but is well on its march to $1 or better.
Expscamtrader pump did not nothing, but harm and injury to its pps. I wonder if that guy is hiding under a rock. I say wait, and load up all the dollar shares that you can. But nothing guarantees that this may tumble way lower.....and then the Chinese New Year's celebration will be filled with tons of sales of AFFY shares at $17. I will certainly enjoy my Côtes de Gascogne with my Argentinian steak. Bon Appetite!
Seeking Alpha had AE post 4 negative articles in the space of a little over 6 weeks which countered the 2 articles EXPtrader posted in the last several months. That is why the stock was pressured in the near term. They are trying to force it down to a level where the majority can cover their position, hence the last 2 months a decrease of 15% in the short position. If BK is imminent or there is absolutely no chance of O coming back why would they cover their position? The tax implications for a short in BK are much less than having to cover without BK. Let the stock trade to 0 and you don't have to cover. So why are they? They are not answering that question so far, which is why I am holding and adding in the low 1's.
1. No one, other than you and your ilk, have said that the outcome of the investigation depends upon resolution of the PEARL AND EMERALD differences. The FDA has not said that. So where is you empirical facts?
2. Where does the FDA validate your sentence? The next sentence is conjecture and assumes Takeda has not already made that determination. Just maybe, Takeda has already made that determination and is part of its justification for supporting the investigation
3. The first sentence has been proven to be false a number of times. Your ploy is to repeat a lie until it becomes truth. It doesn't work that way. Again, you are in your Don Quixote role.
Do you not understand that when you bend truth and insist on lies that the true things you say are stained with the your deception. I read what you write but you are hard to believe because of your character short-comings. Jim
Sentiment: Strong Buy
What the FDA did say was contained in a press release referring to Takeda/AFFY issued reports of O patient anaphylaxis deaths/adverse events and its statement that “Due to the severity of the public health risk, we want to be certain that health care providers stop using Omontys.”
The issues bring ALL of O's background into the scope of the FDA's scrutiny and call into question the patient safety divergence of the EMERALD/PEARL studies. Indeed, the EMA, when it issued its provisional opinion that O should not be approved because its risks appeared to outweigh its benefits also noted that "the study data submitted [by Takeda] might not be fully reliable" among other concerns. Interested readers should also look at my post under titled "O Truth Starting to Emerge - A Sad, Questioned Legacy".
Recall the PEARL statistics:
Sudden death - 2.1% O, 0.3% Epo [O 7x more]
Death from unknown cause- 2.4% O, 1.2% Epo [O 2x more]
Unstable angina - 2.4% O, 0.9% Epo [O 2.6x more]
Arrythmia - 5.6% O, 4.0% Epo [O 1.4x more]
Acute Renal Failure - 8.5% O, 4.3% Epo [O 2x more]
Convulsions - 1.2% O, 0.3% [O 4x more]
Treatment Failure - 3.5% O, 1.5% Epo [O 2.3x more]
In discussing O's poor safety profile PEARL studies results in the January 24, 2013 New England Journal of Medicine, the authors concluded that "[the] increase in cardiovascular events and deaths with peginesatide [O] that was unexpected and remains unexplained..."
Take off your blinders jimlongiii. If the O problem were as limited as you like to believe, the matter would have been resolved long ago and/or Takeda would be on record touting an O comeback rather than deleting O from its website, shutting down O's website, not projecting any O revenues and otherwise remaining silent about O.
Jim I don't believe his bosses let him vary much from his script. If i had a dollar for every time he mentioned the pearl study in a post I might be close to even for what I lost on AFFY when they pulled it off the market in February. He conveniently does not mention the article in the New England Journal of Medicine in which it states the safety and efficacy was no different than Epo and other drugs on the market. In fact if I recall correctly O had a lower incidence of cardiovascular events in comparison to EPO, by about 2.2%. Also the fact that it was designated for full reimbursement by Medicare either late last year or early this year. These groups looked at the data and determined the product was as good as other products on the market. When WBB downgraded and discontinued coverage of affymax they state in the report, "In the firms opinion, AFFY is a company with a good product, which was plagued with unfortunate circumstances." GWP et al conveniently neglect to mention any of these things in their nonstop bashing. Why is so much effort go into a stock down 97% trying to drive it down further? No one on the short side has answered that question as of yet with any credibility.
Let's focus on your point no. 3 - You say Takeda buys O in bankruptcy "at the best price possible". What if Takeda is outbid for O in bankruptcy? After all, everyone (Amgen, Pzifer, etc) likes a good price. So, my point is (and has always been) that Takeda must buy Affy (ergo O) whether it returns to the market or not to protect it's nearly $1billion investment.
It is astonishing how Takeda's investment in O has been stretched by the AFFY longs from $600M to now nearly $1B. Takeda is in the best position to know the true value of O so it will be in the best position to buy, if it wants, the Takeda $180M milestone/royalties agreement in an AFFY BK sale.
My god you sound desperate, posting this same exact #$%$ again and again. Your little forehead must be drenched in sweat since that SA article of yours got stuffed right back up your lower sphincter.