Thursday, December 06, 2018 12:06:55 PM
Out of the 14 jobs posted, half are for Clinical or Regulatory positions. They need to build up the infrastructure in those areas me thinks. It just seems that side of things i.e. managing the clinical trials or dealing w the various agencies is a bottleneck and may have gotten the short end of the straw w/o a strong advocate such as a CMO . I think one of the big faults of Dr. Raj was managing the cash flow to a fault.The last 2 yrs under Raj's watch they didn't have a CMO, and under the prior CMO, Dr Lee Allen, they got an Evomela CRL, and they dropped one of the Rolontis studies to one study only (sometime between May and August 2016) before adding another study a year later (and pushing back the BLA timeline by a year). Hopefully, with the new CMO, Dr. Francois Lebel, and the appointment of Dr. Jeffrey Vacirca to the BoD last month, Regulatory and Clinical will have some strong advocates for the infrastructure needed to push their drugs forward in a timely fashion.
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