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Das es keine kursexplosion gab lag daran das M6G ganz leicht die ziele verfehlt hat (unten rot markiert).

CeNeS Pharmaceuticals (CEN.L) - M6G hits the target profile
CEN.L
Update by Objective Capital , Feb 21, 2007

Key Points:

M6G is equivalent to morphine with lower side-effects – overall, the Phase III trial proves the analgesic equivalence of M6G to morphine, with a significantly better side-effect profile.

Efficacy of patient controlled administration (PCA) M6G now proven – the completed Phase III has laid to rest an important clinical issue. Patient controlled administration of M6G works and is equivalent to the gold standard of morphine.

Mixed picture from primary endpoints… – the trials hit their objectives for analgesia, but just failed to satisfy the test for significance for the incidence of nausea, with a p value of 0.052.

.. but other measures of PONV are highly supportive – the study achieved statistical significance for reduction of other measures of PONV supporting the view that M6G has a better side-effect profile than morphine.

An additional trial will be needed and result in a delayed EU intro – CeNeS is likely to conduct an additional Phase III trial to ‘safely’ gain EU approval and will likely partner up to do so.

CeNeS now has the stuff to convince partners to deal – we believe that the company is now in a position to get partners on both sides of the pond to move towards a deal. The overall data is convincing and fills a market need that is pressing and valuable.

US IND filing imminent – as a prelude to partnering discussions with US companies, CeNeS will file a full US IND within the next few weeks to strengthen its negotiating position.

Overall valuation impact, mildly positive – after the effect of an increase in the likelihood of success, the delay in EU launch, a slight reduction in expected EU royalty rates our valuation has increased slightly to 28p.
 
aus der Diskussion: Cenes Pharma / Krasse Unterbewertung
Autor (Datum des Eintrages): BrauchGeld  (24.02.07 19:57:17)
Beitrag: 19 von 19 (ID:27945998)
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