Longs are soundly sleeping in their beds. They have bought AFFY all the way down from $4 to $3 to $2 to $1 per share. The steady decrease in share price does not interrupt or cause restlessness in their sleep at all. They are lulled by pumper lullabies and dreams of riches. Suddenly, while fast asleep, there is news. Whether it is an AFFY bankruptcy or some FDA imposed safety requisite for Omontys that AFFY cannot timely fulfill, the share price plunges and Longs are swallowed up as if a gaping sinkhole suddenly appeared under their beds while Longs soundly slept.
Latest pumper lullaby by Jagan: "The funny part is, NO LONG here is worried at all."
Truth: Jagan may be right. AFFY longs are prepared to lose all of their "investment" in AFFY. One has to admire their sans souci, but they are prepared to fall on their swords as AFFY careens to BK.
And now the lullabies are again being repeated by dishonest AFFY longs hoping to entice greater fools to buy AFFY. The latest reprise: The FDA cannot interfere with O's reintroduction to the market since it was a voluntary recall.
Another great Maxdad pumper lullaby: "Takeda does NOT need FDA consent to return Omontys to the market."
[The Truth: ALL CLASS I RECALLS REQUIRE THE FDA TO DETERMINE THAT THE FIRM HAS CORRECTED THE OFFENDING PRODUCT or otherwise brought the offending product into compliance, i.e. made safe, before the FDA will allow the termination of the recall and the offending product to return to market. See FDA Regulatory Procedures Manual, § 7-9. Takeda must prove to the FDA that "CORRECTION HAS BEEN MADE COMMENSURATE WITH THE DEGREE OF HAZARD OF THE RECALLED PRODUCT." 46 21 C.F.R. § 7.55(a). ]
A hit pumper lullaby by declaes, seconded by Maxdad: Recently it was reported that patients under Aranesp have anaphylaxis incidents of 0.48%, more than double compared to those injected with Omontys's 0.2%. Among 1028 patients experiencing side effects of Mirera, 0.58% of patients have anaphylactic Shock which is almost triple comparing to the Omontys incidents (0.2%).
[Truth: Declaes/Maxdad compare Aranesp's/Mircera's anaphylaxis percentage compared to all adverse
events [apples] to decry O's anaphylaxes percentage to O's entire patient base [oranges].
Here is the truth comparing apples to apples with respect to Aranesp to illustrate the point:
One can calculate the same percentage basis for Omontys expressed as # O anaphalyctic shock incidents/O
total reported incidents to compare against the .48% Aranesp percentage.
1st Number of adverse side effects reported for O by the Wall Street Journal: 12 patient deaths and 98
serious adverse events [AE]= 110 total reported AEs for Omontys.
2nd AFFY/Takeda disclosed anaphylaxis adverse incidents .2% out of 25,000 patients treated equals 50.
3rd Now, divide 50 O total anaphylaxis AE by the 110 total O AE= 45.45%.
Conclusion: It appears that Omontys' allergic reaction rate compared to all O AEs is 45.5% compared to the
Mircera .48% allergic reaction rate compared to all Mircera AEs. O's incidence of anaphylaxis out of total
adverse incidents is about 100 fold higher than Arenesp's.
Indeed, this cursory analyis reaffirms the results previously calculated and reported by Raymond Baird analyst Christoper Raymond. In his research report, published soon after O's recall, he determined that "[L]ooking at FDA’s adverse event database for Epogen, Omontys appears to confer a 100-fold higher incidence of hypersensitivity and an 8.5-fold higher incidence of drug-related death (and that’s new)."]
The latest lullabies: The Seeking Alpha articles have pumped AFFY twice before. The third Seeking Alpha article, although it just restates the AFFY long unicorn, rainbow and skittles fantasies of royalties trust and buyout, has managaged to do it again. Maybe this time is different.
Judas Sheep Maxdad croons this pumper lullaby as he leads the AFFY Bagholder flock to financial shearing, skinning, gutting and butchering: YES, BANKRUPTCY (IMO) IS NOT IN SIGHT AND WOULD HAVE ALREADY OCCURRED IF IT WAS PREFERRED OUTCOME.
Gotta love jagan's greatest pumper lullaby: Takeda's withdrawal of O's application for EMA approval is Takeda's preparation for a lowball AFFY buyout offer of $5-6 per share! I absolutely love that tune. How absurd and outlandish can delusional longs really be? Jagan's lullaby is epic in that regard.