Replies to post #104944 on Biotech Values

[DewDiligence]

More on Merck KGaA’s Cladribine for MS:

http://www.reuters.com/article/idCNLDE68N04J20100924

[The CHMP], whose view is invariably adopted by the European Commission for approval decisions, found that the benefits of cladribine tablets did not outweigh its risks. Regulators mainly took issue with cases of lymphopenia, a lack of a certain type of white blood cells, and with the risk of cancer, the head of Merck's pharmaceuticals unit, Elmar Schnee, told Reuters on Friday.

Cladribine is still nominally viable in the US. Merck resubmitted the Cladribine NDA on 6/8/10 (#msg-51012919) after having received a Refusal to File letter in Nov 2009 in response to the original NDA submission (#msg-44040202). Merck refused to divulge what the problem was, leading to speculation that the FDA had insisted on another phase-3 trial (#msg-46949655). If the FDA takes 6 months to act on the resubmission, a decision should come by early December.

[DewDiligence]

CHMP denies Merck KGaA’s appeal on Cladribine:

http://www.reuters.com/article/idUSLDE70K05G20110121?feedType=RSS&feedName=rbssHealthcareNews&rpc=43

The FDA PDUFA date is next month (#msg-57103405), but the odds do not look good.