Replies to post #54868 on Ariad Pharmaceuticals Inc fka ARIA

[greggors]

Maybe ARIAD is one the first Biotechs to design and manufacture very potent multi-targeted drugs, and along with it comes a learning curve...as witnessed in the early development of 113.

[zuize]

... I guess nothing learned, there is nothing wrong with Iclusig, nothing wrong with management's decisions regarding dosage in the past, it's FDA's fault, it's shorts' fault. LOL! Iclusig's safety issue was out there all of last year unless you buried your head in the sand, it didn't come out of blue all of sudden like AFFY's Omontys. I am sure at least in the back of your mind for the past year, you wished you had listened to "shorts" just for this one time.

No question that Iclusig a life-saving drug and should NEVER be pulled from the market. This was proven last December when the strong voice from Patients Avocacy groups and many doctors have forced FDA quickly reversing their decision Iclusig within 60 days.

To see who should be blamed for the crash last October. Let's take a close look at how FDA made their decision:

FDA's decision was based on the AE's numbers reported from the hospitals which was ~20%, while the figure from the clinical trials was around 12%. Comparing 20% vs. 12%, is it that significantly different that FDA had to pull the drug completely from the market and terminal all the ongoing trials which cost Ariad millions dollars in setting them up? Did they really look into where those numbers came from and the doctors involved in generating the data? And what about the doctors' credentials based on cancer patients survival rate under their cares? Did they look into any existing patients out there who rely on Iclusig to suvive? Of course they did not, that's why only 3 weeks later on 10/31/13 they had to issue an update to allow Ariad providing Iclusig to patients under IND program, and then 6 weeks later letting the drug back to the market under restriction label.

FDA's lousy decision making caused Ariad stock price dropping from $18 to $2/share. If they really studied the issue carefully and issued a restriction label rather than completely withdrew the drug from the market, then the stock price would probably drop from $18 -> $10, not a massive loss of 90% of its value.

[aura]

PRAC's decision clearly puts what was wrong with FDA's action. FDA should have done exactly what PRAC did - do their due diligence appropriately and as the decision clearly puts it, the risk-reward is heavily biased towards the reward. I remember the comment by Pazdur which clearly put the motivation behind FDA's or his move... which was not certainly what PRAC followed.