MEI Pharma, Inc. (MEIP)

[bladerunner1717]

They have well over 50 million in the bank. Short term investments are also counted as cash...most overlook that. How much does a phase iii cost?

Figure ~$100,000/patient. Too much, too long and too complex for a micro-cap biotech to handle, IMO. (Yes, I know about DNDN with Provenge.) Furthermore, in the hands of a Big Pharma, Pracinostat can be tested in other indications and in other combos that MEIP could never afford to do.

From ASCO, 2014:

Contemporary clinical trial processes are so arcane and Byzantine that a new industry has arisen to shepherd studies through the tangled regulatory underbrush: commercial contract research organizations (CROs). Burdensome auditing and documentation requirements mean that it is usually easier for pharmaceutical sponsors and academic medical centers to outsource data management tasks to for-profit CROs, which themselves introduce new hurdles for investigators and have been called by some, “a proliferating cancer within the cancer trial process.” Repeated queries from CROs about minutiae can seem financially self-serving to investigators, and it is unclear how often such compulsive oversight translates into improved trial quality or patient safety. As a result of the increasing regulatory requirements and the need for CRO involvement, the cost of research per patient on a phase IIIA oncology trial has ballooned from an average of $3,000 to $5,000 in the early 1990s to a range of $75,000 to $125,000 in 2013. In just 3 years (from 2008 to 2011), per-patient clinical trial costs increased by 70%, without reassurance that we are obtaining proportionately more quality for those research dollars.

http://jco.ascopubs.org/content/32/5/376.full


Bladerunner