And that OS is the gold standard. That guidance is not exel specific, but for all onco product. If you come to FDA with only PFS without OS, your product will be Pazdur(ed).
I think that EXEL is doing this in Comet trials, but a failure on OS endpoint and just PFS for FDA approval will not salvaged for approval.
I have followed several FDA decisions and the companies have been Pazdur(ed)! I really think that it is safe bet to follow Pazdur's guidance. once the drug gets his thumbs up, it is with high certainty that it gets approved. I also have seen Astellas went against Pazdur and the end result were devastating.
I will take you advisory with a grain of salt! Please reade your argument and justification, I could sense hypocracy. You are using fiduciary obligation as justification if it suits well, yet suggesting breaking it so that EXEL will not be able to realize the economic benefit from COBI.
All of this is rumor until substantiated. We'll see if your assumptions will or will not materialize. The risk/benefit remain to be the same. Risk on!
The CFO is correct as the cost per sale have been incresing due to increased manpower expenses., therefore their marginal profit is currently on negative. So an increase in revenue will mean marginal profit to fall into positive territory.
You can twist it anyway you like it.
He already one of them ole timers on this boad, didn't you notice.
Where the hell is mitch2bdog? I am waiting for a smackdown. Sell all your shares and be happy!
It takes one to know one. So are you the leader?
Hang it up Mitch! Short won.. It will take dara to gain more than 300% for you to taste a profit, while shorts have feasted on your behalf!
From the southside of 49 square miles... It has been a quiet sunny day. Nothing new is brewing just yet. So dont be the Babikian. Just like some here, I have a dog on this fight, 4,500 shares on long side. Just tired of hearing the buy out rumor.
Mitch2balls, ahem, Mitch2bdog, will you care to answer! Please justify the addition of 20 salesforce addition that is still useless while you're at it...
My take, the theraphy in the US for Breast cancer is so competitive that these products cannot compete. Have you done your due deligence on the history of the licensed approved drugs? If you did, that should provide you with the answer to your question.
There is no use in beating the dead horse! Dara got few baroowed FDA approved drugs with close to nothing sales revenue, eventhough a ramp up salesforce and one clinical drugs that is still unproven in a larger scale. Common sense dictates that the DARA is garbage company, but common sense is not so common.
Wah wah wah! Another bag holders that cannot take criticism.
The is world wide web. Cant control who can or cannot post. Sell you shares, it helps on your blood pressure.
Mitch oh Mitch, you really need to hang it up. The only way this POS will trade at $25 on Monday is through RS or one of Mondays in a year 2030.