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ACADIA Pharmaceuticals Inc. Message Board

  • cansomeonetellmenowpls cansomeonetellmenowpls Apr 24, 2013 8:17 PM Flag

    From 8K filed on 04/11 - you longs need to read this... this is going down...

    "ACADIA announced that it is currently focused on completing the remaining elements of its pimavanserin PDP development program that are needed for submission of an NDA. These include customary supportive studies, such as drug-drug interaction studies, and Chemistry, Manufacturing and Controls, or CMC, development, such as stability testing of registration batches. Subject to changes that could result from future interactions with the FDA or other developments, ACADIA is currently targeting an NDA submission near the end of 2014. "

    This means END OF 2014 before they submit to NDA... they are not DONE right now! THey still need to complete the "remaining elements" which is very cost intensive. Drug-drug interaction studies need to be done...

    So, END of 2014 before they submit an NDA... then 1 year to get approval... this means MORE THAN 2 YEARS before an approval...

    facts matter.

    Sentiment: Strong Sell

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    • I would strongly encourage you to think very carefully about the operative word in there "CURRENTLY". They were also planning on another Phase 3 and that didn't happen. Better cover short stuff. You're about to get creamed.

    • cansomeonetellmenowpls cansomeonetellmenowpls Apr 30, 2013 12:42 PM Flag

      So longs, what about these additional things they STILL need to do? drug-drug interaction studies... in other words, they have no idea how it will react with other drugs. What if it reacts to other Parkinsons drugs in a negative way? no one knows yet because they HAVEN'T DONE THE STUDIES yet. They don't even have chemistry and manufacturing and controls set yet! You're talking YEARS and many millions of dollars to go.

    • I'm sure the Baker Bros. were very aware of timelines and associated hurdles ("remaining elements") prior to filing. Yet... get this....they had a 200% increase from their previous investment, and this was from the year-end 2012 13-F filing, before there was any news out about ACAD getting a pass from the FDA about further Ph III trials. The Baker Bros. occasionally get it wrong, but not often, and not with this much at stake. They know a winner and are willing to wait; I'm just along for the ride.

      Sentiment: Strong Buy

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