Replies to post #195323 on Biotech Values

[marthambles]

FGEN: An additional near term (although not fundamental) risk IMO is the possibility of an announcement by AKBA of a partnership to take it into phase III. It would seem likely that such an announcement would cause a fairly significant, if temporary, downtick in the FGEN share price.

[DewDiligence]

ESPR updates investors re EoP2 FDA meeting:

http://finance.yahoo.com/news/esperion-therapeutics-provides-further-updates-203000159.html

Esperion plans to conduct multiple Phase 3 clinical trials that will separately evaluate patients with statin intolerance, as well as patients who are inadequately treated despite maximally tolerated statin therapy. This dual strategy will leverage the profile of ETC-1002 to differentiate the drug in the statin intolerant patient population, while also preserving the opportunity to develop the drug as an add-on to maximally tolerated statin therapy.

For statin intolerant patients who have a high unmet medical need, Esperion is working with key opinion leaders and will continue to seek advice from global regulatory authorities on the design of the Phase 3 program. Specifics of the Phase 3 development program are anticipated to be finalized by the first half of 2016.

For patients on maximally tolerated statin therapy who require additional LDL-C lowering, Esperion will plan to conduct efficacy and long-term safety trials. FDA has encouraged the Company to initiate a cardiovascular outcomes trial promptly, which would be well underway at the time of the New Drug Application submission and review, since any concern regarding the benefit/risk assessment of ETC-1002 could necessitate a completed cardiovascular outcomes trial before approval. Esperion intends to initiate a global long-term safety study for ETC-1002 by the end of 2015.

CC today at 5pm ET.