du bist raus? das war aber nicht sehr weitsichtig. geduld zahlt sich hier aus, ich hab nochmal kräftig nachgekauft.
das fda approval kommt erst noch, im august will man einen globalen partner für den vertrieb vorstellen. der anstieg der letzten tage resultierte wohl daraus, dass bekannt wurde, dass eine firma namens "RENAISSANCE TECHNOLOGIES LLC" Shares im Wert von 6Mio$ gekauft hat. eine FDA commisioner namens Margaret Hamburg ist die Frau von dem Finanzchef von Renaissance. Wenn man jetzt 1+1 zusammen zählt, kann man sich denken, was das bedeutet. www.nasdaq.com/quotes/...ompanyname&sorttype=0&page=14
zusammenfassung des investors talk von gestern:
"DRUG GOAL: 1st line therapy for early t2dm. Hopes to slow, stop and even reverse diabetes!
AFFINITY 1: Non-inferiority within 4% difference. This trial includes the titrate to treat paradigm which strongly favors Affreza versus injectable insulin. They expect to see superiority but they just have to show non-inferiority.
AFFINITY 2: They only need to show a 0.5% reduction in A1c which AL believes will be easily achieved. Treatment is complete and they are only in their 4 week follow-up phase. Follow-up will be complete the 1st or 2nd week in June.
POST MARKETING TRIAL: FDA recommending a phase IV to test in kids as young as 4 years old. FDA is anticipating product approval!
PIPELINE: Basal pump in development … 3 years away. Al will be 90!
PULMONARY RISK: The FDA wants to show that it works in patients with COPD but it is not required for approval. It will impact labelling. The problem is trying to get patients enrolled. 60 sites enrolling patients.
CARDIOVASCULAR RISK: There is a meta analysis on cardiovascular risk. Very low risk.
EU: Working on this in parallel with FDA.
PARTNERSHIP: They went pretty far with a Chinese partner but they are currently most interested in a global partner that would not want complications with regional partners. "I can’t imagine that we wouldn’t have a partnership before approval but hopefully sometime this year. We are really NOT anxious to do something before data.""
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