Intellipharmaceutics International Inc. (IPCI)

[fred198484]

This is encouraging - have to believe we will see a quick approval of Rexista:

Wire: Bloomberg News (BN) Date: Apr 5 2017 13:15:15
Opioid Epidemic Is FDA’s Top Priority, Says Pick to Head Agency


By Anna Edney
(Bloomberg) -- Opioid painkillers that have led to
thousands of deaths and new drug addicts should be the highest
priority of the U.S. Food and Drug Administration, said Scott
Gottlieb, President Donald Trump’s pick to lead the agency.
“The opioid epidemic in this country has staggering human
consequences,” Gottlieb said Wednesday in a hearing before the
Senate Committee on Health, Education, Labor and Pensions. “I
think this is the biggest crisis facing the agency.”
Likening the widespread abuse of opioids to the outbreak of
Ebola virus that ran rampant in West Africa, Gottlieb said that
the agency would have to pursue a number of paths, such as
working with drugmakers seeking approval for alternatives and
abuse-deterrent versions of the drugs. More than 33,000 people
died from opioid overdoses in 2015, according to the U.S.
Centers for Disease Control and Prevention.
The agency would “push the policy boundaries” for approval
of safer opioids and other alternatives if he’s confirmed,
Gottlieb said. “It’s going to be an all-of-the-above approach.”
Gottlieb is likely to be confirmed by the full Senate when
he eventually gets a vote. His comments to the committee
Wednesday seemed to assuage concerns by some senators on the
drug crisis as well as other issues, including potential
conflicts of interest that come from his work as a consultant
and investor.

Number of Hats

A former FDA staffer who left the agency to work in the
business world, Gottlieb also faced questions on his ties to
health-care companies. Financial disclosure forms show he earned
millions of dollars from various investment banks and
pharmaceutical firms last year and in the first part of this
year, including $1.85 million for his work as a managing
director at T.R. Winston & Co., an investment bank that raised
money for a number of public companies. 
“You do wear an extraordinary number of hats,” said Senator
Patty Murray, a Democrat from Washington. 
Gottlieb replied that at the FDA, he would be guided by
science. If confirmed, he would resign from T.R. Winston, divest
interests in more than a dozen companies and temporarily recuse
himself from making decisions on at least 20 more where he has
financial interests or was paid consulting fees, including
GlaxoSmithKline Plc and Bristol-Myers Squibb Co.
“The lives and the futures of families like mine are
affected by the decisions made by the FDA,” Gottlieb, whose
wife, children and parents were at the hearing, said in his
opening statement. He pledged to make sure “the FDA puts their
interests first in everything we do.”

Drug Prices

Gottlieb has previously spoken about lowering drug prices,
a Trump priority, by speeding approval of generic drugs. He’s
particularly focused on complex medications that combine old
drugs with newer delivery devices, as well as those with
unusually complicated formulations.
In his prepared remarks, Gottlieb urged rejection of what
he called a “false dichotomy that it all boils down to a choice
between speed and safety.” Instead, he wrote, if the FDA
leverages new technology and better science it can improve
efficiency and safety “and also remain faithful to FDA’s gold
standard for regulatory conduct.”
Gottlieb, 44, served as a deputy FDA commissioner from 2005
to 2007. He hasn’t faced the same criticism from Democrats that
other Trump administration choices have, such as Health and
Human Services Secretary Tom Price and Supreme Court justice
nominee Neil Gorsuch.
In addition to his consulting and investment work since
leaving the agency, Gottlieb has also been a fellow at the
American Enterprise Institute, a conservative-leaning Washington
think tank. He was trained as a physician and completed his
residency in internal medicine at Mount Sinai Medical Center in
New York after graduating from the Mount Sinai School of
Medicine in 1999. He earned a degree in economics from Wesleyan
University in 1994.

To contact the reporter on this story:
Anna Edney in Washington at [e-mail]
To contact the editors responsible for this story:
Drew Armstrong at [e-mail]
John Lauerman