Alexza Pharmaceuticals Inc. Message Board
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Europe Approval
To those that have an idea, what are the chances of it being approved in Europe while it is in limbo in the United States?
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It's very likely a Europen approval can happen at any time.
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I also expect Europe to approve ALXA meds soon, there.
- 2 Replies to humfreebogart
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hh..............................
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IMO, the EU will approve the Staccato delivery system. Big question is how soon.
With the FDA, its anyones guess.
GLTA longs!
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I dont think this is in "limbo" in the US, it failed.
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I would expect that to happen very soon. I think it is very likely any day.
- 1 Reply to richmansal
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Any day? Really? I thought they said they were not going to have the EU questions answered until Q3. It will not be approved before the questions are answered. Also, if there is a mfg issue preventing US approval, it most probably will prevent EU approval as well.
What is your basis for the "any day" prediction?
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A good quistion, I think it will be approved in Europe.
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Well, it depends upon the current issue resolution of course. But based on the release today, they said the response to the questions were going in in Q3, then they still have to do the inspection, so realistically a decision date will most probably be Q4 the earliest. Going with the idea that they feel the mfg issue can be resolved relatively easily, it may not take that long to fix. That would suggest that there should be no conflict.
However, if the EU is not happy with the responses and/or identify something new during the inspection, then all bets are off on the timing of EU approval.
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