Saturday, July 20, 2013 12:19:28 AM
Orphan drug status could go either way. Last time we got a No straight away. I have spoken to Dan and he thinks they have submitted a very good package, but it's upto those who decide. Now it could go 1 of 3 ways.
1 No Orphan statues.
2 we need more information
3 Orphan status approved.
If we get 2 or 3 this would be positive. Some will bash 2 but we got a big fat 1 last time we requested it so get a 2 and that is pretty good news. Not to long to wait now, and we have 2 other indications submitted after that. My only concern with Cervical is that we have to overcome being under 200,000 people. I know the difference between this submission a last is that we have not included CIN, so should keep us well below the 200,000 threshold. Only time will tell.
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