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Monday, March 24, 2008 5:37:03 AM
OK, I will take a try.
Junoven by any name has NO chance of being approved by the FDA based on the new data (argument below). To present an "investment thesis" in the stock requires an argument that acknowledges this fact. If anybody would like to procead on this I am all ears.
Does the remaining pipeline justify a buy?
What is the EU story?
Can they possible perform another trial on a surragte endpoint?
To be honest, I am not in IDMI either way. If somebrody has a reasonable argument to be in (that doesn't just ignore the Juno trial data issue) then I will happily debate. I do like to invest in somewhat busted biotechs.
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When IDMI took Junaven before the FDA, they got shot down on several serious issues. In order:
. The trial had no defined stat plan or endpoint
. Juno only showed a benifit when another UNAPROVED drug was used concurrently. W/o the unapproved drug, Juna didn't show a benifit.
. The database was seriously flawed.
Getting a drug aproved on a single trial requires quality data. This trial was the complete opposite. There is NO chance that adding a few UNBLINDED datapoints will change the real issue.
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