Damn!

Anyone can read your Mexican study with less than 10% US patients. That must be a new record for PAH bribery. See below-note that a patients 6MWD distance could actually decrease on MACI treatment by 14% and it was not considered an event.
That is really something. No wonder this pig got approved.


Outcome Measures
The composite primary end point was the time from the initiation of treatment to the first event related to pulmonary arterial hypertension (worsening of pulmonary arterial hypertension, initiation of treatment with intravenous or subcutaneous prostanoids, lung transplantation, or atrial septostomy) or death from any cause up to the end of treatment. Worsening of pulmonary arterial hypertension was defined by the occurrence of all three of the following: a decrease in the 6-minute walk distance of at least 15% from baseline, confirmed by a second 6-minute walk test performed on a different day within 2 weeks; worsening of symptoms of pulmonary arterial hypertension; and the need for additional treatment for pulmonary arterial hypertension. Worsening of symptoms of pulmonary arterial hypertension included at least one of the following: a change from baseline to a higher WHO functional class (or no change in patients who were in WHO functional class IV at baseline) and the appearance or worsening of signs of right heart failure that did not respond to oral diuretic therapy. An independent clinical event committee adjudicated, in a blinded fashion, all events related to pulmonary arterial hypertension and all deaths that were reported up to the end of treatment, including whether death was due to pulmonary arterial hypertension.
Prespecified secondary end points included the change from baseline to month 6 in the 6-minute walk distance, the percentage of patients with an improvement in WHO functional class at month 6, death due to pulmonary arterial hypertension or hospitalization for pulmonary arterial hypertension up to the end of treatment, and death from any cause up to the end of treatment and up to the end of the study. Safety end points included adverse events and laboratory abnormalities.

 

Just so we are clear: you were wrong about hospitalizations, and a moron with too much time on his hands. Been a slow year?

 

No, I am a different Gilead Millionaire. in 5 years I have amassed 1.5 Million in stock. How about you?

 

Ooh. That put me in my place. Get a life moneybags!

 

You tried to get docs to buy a mortality benefit by saying maci has MORTALITY and morbidity benefit but all it really has is clinical worsening..no matter what kind of emphasis you place on the word MORTALITY

Death is the hardest endpoint and no oral improves that..
Hospitalization is the 2nd hardest endpoint..and damn near impossible to make happen in the U.S...
The rest of clinical worsening endpoint is soft soft soft and open to bias, adjudicated or not...

Personalized medicine is all about personalizing to the population and the patient...the same 3rd world PI's from the Seraphin trial are now busy battling Ebola...that illustrates the difference between ex US and US medicine..

Your garbage data doesn't apply in the U.S.

 

Every other clinical worsening primary endpoint in any PAH study up until Seraphin included hospitalization AND hospitalization was the MOST FREQUENT component of those combined clinical worsening endpoints......

add to that the fact it costs the healthcare system $70,000 each..

The devil is in the details and payers won't pay for a drug that has marginal benefit in the U.S...PAP it like you do for your digital ulcer patients!

 

Can we talk about 6 Minute walk now? Thats the real life version of the emperors new clothes.

That is one wimpy ass drug all wrapped up in a lot of mumbo jumbo around faux receptor binding and "tissue penetration".

 

Yaaawwwwnn....

 

WOW I AM GETTING OPSUMIT SWITCHES TO LETAIRIS NOW....THANKS ACTELION FOR OVER PROMISING AND UNDER DELIVERING!

 

It is so fun to read these desparate posts by gilead trolls. Letairis is dead and ambition is so bad that you people are not even talking about it. Don't worry, as soon as your marketing department comes up with a strategy for ambition it will be too late. We have been bringing it up to the customers for you because it left more questions than answers. Talk about edema, ambition just raised the bar.

 

The company had earlier said it is in “advanced discussions” with potential white knights, which reports identified as investment Bank of America and hedge fund United General. The investors supposedly crafted a $385 million financing package, but no mention of the deal was made in today’s 8-K filing.

 

Number of combo patients needed to treat to see Edema vs Monotherapy: 7

Number of combo patients needed to treat to see a DC due to Edema: NS

Number of combo patients needed to treat to prevent a hospitalization: 12

Thats right..primary endpoint, U.S. hospitalizations, 100% combination, prespecified, protocol defined, and randomized.

Lets put that up against Seraphin...NO, NO, NO, and...NO!

 

I hate to admit it, but our Maci is not what we thought it would be.

 

Bloom is off the rose with Opsumit. Docs are using a lot more letairis in my state

 

Yes but while no specific items are mentioned, there will be major discounts given on large orders throughout November and December.

 

Yes like symphony=7k per patient what's next 10k!

 

My God, this company and its employees never change. I can go away for a year and come back to this board and you are still full of yourselves. The most overpaid cry babies and
pedantic jerks I have ever had to deal with! EVER!

 

Hey thanks for stopping by we've missed you so! Have a nice weekend and don't be a stranger! And thanks so much for putting us in our place we welcome any and all constructive criticism from such honorable ex-Actelioners such as yourself. Happy trails on your high horse there! We will try, try, try to be satisfied with our huge bonuses

 

Actually you're correct, you overpaid moron. Maci is purely driven by excellent marketing and seeding trials, you have zero impact. So go fetch another Latte for your seeding trail physician.