Ireland's top selling newspaper The Sunday Independent, reports today that the US drugs regulator, the FDA, had not ordered the suspension of the clinical trials of the multiple sclerosis drug Tysabri but a panic reaction by Elan and Biogen prompted the decision,�to head off the liklihood of legal proceedings.
Business editor Shane Ross writes that a serious�rift has divided Elan and the US Food and Drugs Administration (FDA) over the suspension of the drug which caused the collapse in Elan's share price last week. Fierce accusations are being made that the company acted too hastily. It is emerging this weekend that the shock decision to suspend the drug was taken by Elan and its partner Biogen without the agreement of the FDA.
Yesterday, sources at the FDA were keen to distance themselves from Elan's decision. A spokesman for the authority said that they "were made aware of the decision".
SO AS SOON THE DATA IS COLLECTED THAT NO CASES OF PML LINKED TO MONOTHERAPY THE RE-INSTATEMENT SHOULD BE RAPID
AS I HAVE DESCRIBED THIS WEEKEND - THE DYNAMICS OF THE AVONEX + TYSABRI INTEREACTION IS COMPLEX AND POTENTIALLY VERY POTENT - THUS THAT WILL TAKE SOME TIME TO FIGURE OUT - BUT IF NO PML CASES IN THE MONOTHERAPY TREATED PATIENTS IT IS PLAIN STUPID AND UNFAIR TO MS SUFFERERS TO NOT BE ABLE TO TAKE TYSABRI MONOTHERAPY
HOPEFULLY MORE PEOPLE WILL BEGIN TO FIGURE THIS OUT
I notice that your post is a report about a report. It appears to be opinion, not fact.
I have not yet seen any reliable report of a rift between the FDA and Elan/BIIB. The FDA web site says that the FDA supports the BIIB decision to suspend Tysabri dosing.
We still don't know what is the real interaction between the FDA and BIIB/Elan. We know that the FDA made statements about wanting Tysabri back on the market, but that does not establish what was really going on in those talks.