From the lawsuit allegations: AFFY knew about serious allergic reactions from EMERALD studies, but hid the results. FDA advisory panel questioned EMERALD studies reliability due to its open label nature and high rate of patient drop out and inconsistency with PEARL results. The EMA, at the time Takeda withdrew its O MAA, commented that the study results Takeda filed in support of O might not be reliable.
Takeda may have a very difficult time under such circumstances convincing the FDA to allow O back to market without a serious clinical study to prove safety. No unmet medical need. Proven, safe alternative ESAs that are industry standard. It may just be better for Takeda to walk away and cut its losses from the O disaster. Why did Takeda decide not to market O in Japan in 2011 if O was such a great drug as AFFY longs claim?
truth? What truth? All these deaths may not have been caused by the drug. That's why there is an investigation going on. The SA writer is obviously ahead of himself making doomsday speculations, But they are just that, speculation, nothing more. No one knows what caused these deaths. On the other hand the vast majority that used the drug had no adverse effects. This is still a mystery until facts show one way or the other. This article is just another attempt by those who are on the short side.
GWP...I completely agree on your FUNDAMENTALS POINT...Fundamentals (HISTORY) says that there are NO DRUGS with the mortality profile of Omontys that have been permanently pulled. Out of the 53 that have been pulled since 1960 ONLY ONE even came close to O's mortality and AE profile and it had a half dozen almost identical antibiotics with great safety profile. CONVERSELY THERE ARE HUNDREDS OF DRUGS WITH FAR WORSE MORTALITY PROFILE ON THE MARKET TODAY!!! Just being with Tylenol...which CNN had a feature story just a couple of days ago that there have been an average of 150 FATALITIES PER YEAR FROM TYLENOL OVER THE PAST 10 YEARS!!! Using your contorted logic Tylenol should have been pulled a long time ago.
The one thing you have been working like crazy is the fact that the investigation isn't over and Omontys hasn't (YET-YET-YET) been restored to the market...and as long as such uncertainty exists the BASH TRASH WHACK PACK can and will say just about anything to spread fear...That "advantage" will soon be ending and I hope like hell that you've held every one of your short shares when that happens!!! You won't be able to offer up your twisted stories once the truth has been revealed and Omontys returned to market!!! You'll just disappear, broke and broken after almost a year of spewing forth your perverse garbage hurting g-d knows how many people in the process...YOU MY FRIEND ARE THE JUDAS GOAT!!!
The litigation spells disaster for AFFY longs. Go ahead. Keep ignoring AFFY's 8,000 lb gorilla. All the AFFY longs say Takeda wants to buy AFFY and take on the litigation as its own. Really? Takeda is going to pay hundreds of millions to obtain hundreds of millions in litigation liabilities?