i don't see any reason to blame novartis. from other posts it's clear that the FDA put off all meetings for a month and i personally wouldn't blame them for leaving town for awhile and not making any decisions. It's my understanding that novartis was expecting a reply but has not received it. I also don't think that the FDA can say anything publicly on this at this pointin theprocess.tom
Jeff....why has novartis gone silent?
Why do you think that they have gone silent Jeff? What's the reason for it? They should have had the reply before all this horrible misery started...can you shed any light on this?
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Tom,they were to have the decision a week before the disaster...they seem to be just fine now releasing current data, they should have heard by the 7th on the appeal...So what you are saying doesn't make sense to me...the ruling was given supposedly..I am not blaming anyone, I am just asking why the hold up when they knew on the 7th.
I have no answer for this. I can only surmise, and I have no knowledge of this, that there is continued dialogue going on between Novartis and the FDA in the wake of the appeal decision.[This message has been edited by Jeffrey Roberts (edited 09-20-2001).]
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