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Biotech / Medical : Sonus Pharma (SNUS) ? Opinions

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To: nanoh who wrote (264)3/20/1998 3:27:00 PM
From: (no name provided)  Read Replies (2) of 384
 
Not quite accurate:

"- they should assemble everything at the end of march or first few days of april."

No. They won't even know what to submit before their meeting in late April.

"- then FDA will have 90 days to respond"

Wrong again. PDUFA rules allow the FDA 180 days AFTER the receive the resubmitted package.

"- usually the protocol of trials is agreed with the FDA before the trials even start"

True. But it is no guarantee that the company will stick to the protocols.

"- some time ago FDA lost a legal battle with SNUS this action looks really as a repay."

Maybe. It may also mean that the Echogen agent has some serious problems.

- ABBOT will take much bigger role in trials.

So? They were responsible for manufacturing and that is one of the problems.

"- there is no any evidence of any safety problems."

Except for the dogs it killed.

"- this stuff will be aproved and SNUS partner ABBOT is much powerfull
then MOBI partner"

Wrong. Mallinckrodt is the world-leader in contrast agents. Abbott is a leader in diagnostics NOT contrast agents.

Kafka666
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