Saturday, November 28, 2015 9:09:10 AM
tome of background info on why deterring "legal malpractice" matters -- extensive Case Law cited (291 pgs).
https://jenner.com/system/assets/assets/5514/original/Sanctions_20Under_20Rule_2011-Complete_2010.pdf
Rosen's gotta be worried given regs, including among other things that caught me eye, the "reasonableness of inquiry" standard (p. 27/33) and a lawyer's "continuing obligation" to investigate the ongoing merits of any legal action. p. 32/38). Lots of cases cited where judges dealt sanctions.
Recall also Judge Faila is familiar with market manipulation -- she's an ex-Asst US Attorney for the Southern District of NY no less, and a former member of its Securities and Fraud Task Force, 2002-2004.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=118670334
Science-wise, a very nice surprise to see Fast Track awarded for B-OM. Orphan for K-Pancreatic and Fast Track for B-ABSSSI next in queue. Below, link to FDA slide deck on Breakthrough Therapy designation. Most comprehensive overview I've come across. At some point, BT might be another FDA feather in CTIX 1st in Class Onc/ABX cap.
(Repost)
"Breakthrough Therapy Designation: Exploring the Qualifying Criteria" (April 2015)--by phase-stage, # of supporting trials, biomarkers, Orphan Designation, study type, etc)
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM447162.pdf
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