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I had a little talk with the head of Investor Relations from Allergan David Nakasone. I was wondering why we haven’t heard anything regarding Apaziquone from Allergan yet. David told me that FDA has not yet responded about the data package Allergan/SPPI filed to them about the two single installation trials. David did still think that they will respond to Allergan/SPPI in 2012 and set a time for a meeting later this year.
Regarding Europe, Allergan is waiting from the response from FDA to decide what to do in Europe. As David said, they would probably follow FDAs word and do the same thing in Europe, but he couldn’t confirm that for sure. So if FDA allows filing an NDA with pooled data there is a very good chance that Allergan will file an MAA to EMA also.
Regarding the two multiple installation trials David confirmed to me in the phone that they vas both fully enrolled in October 2012. Data would be around year end 2014 David said, but the primary endpoint is different because it is time to reccurance and not recurrance rate after 24 months at it was in the single installation trials.
Investor in stocks in about 5 years with some very good profits. Focusing on Biotech and Value stocks. Active investor...
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two multiple installation trials – so they are progressing these trials as of now ?
Thanks. Let me link this useful info from my blog. Great digging as always. Keep it up