Yes! FDA Approval Creates a Huge Buzz for $BDSI !! ( So why the sell-off? ) #BioDelivery Sciences

Yes!  FDA Approval Creates a Huge Buzz for $BDSI !!  ( So why the sell-off? ) #BioDelivery Sciences

If you read Zacks today,BioDelivery Sciences International (NASDAQ: BDSI) is the greatest stock since that other stock they loved. You know, that one on the Pink Sheets!  

So what’s the story?

Here’s the latest press…

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Let’s See the Buzz!

 

I am not sure where Mark is going with this, but I can hear the howl:

Here is how Amel is playing his Call Spread:

BioCourse sees a squeeze tomorrow!

Keene took a profit selling Calls…

Mussocpa calls for a rally through $6:

Mark is giving himself a pat on the back selling into a “fake” pump. Now if a pump is fake, than that means the momentum is real? He wants it down tomorrow…

Quark buyout conspiracy:

Donna says…. Conclution. She does not want you to sell cheap to manipulators!

Mussocpa throws a great image of a sinking ship as he buys in to BDSI!

Roberto notes Janney initiates at Neutral… Target $7. William Kim looks at $4 as a more fair price.

 

Latest News:

FDA Approval of BELBUCA™ (CIII) (Buprenorphine HCl) Buccal Film for Chronic Pain Triggers

Milestone Payment of $50 Million to BioDelivery Sciences from Partner Endo Pharmaceuticals Milestone Payment Provides BDSI Anticipated Cash Runway to Approximately Mid-2017

BioDelivery Sciences International, Inc. (BDSI) and its partner Endo Pharmaceuticals Inc. (Endo), a subsidiary of Endo International plc (ENDP) (ENL.TO), announced earlier today that the U.S. Food and Drug Administration (FDA) approved BELBUCA™ (CIII) (buprenorphine HCl) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. FDA approval of BELBUCA has triggered a milestone payment to BDSI from Endo of $50 million pursuant to the 2012 worldwide license and development agreement between BDSI and Endo for the development and commercialization of BELBUCA.

It is anticipated that BELBUCA may become commercially available in the U.S. during the first quarter of 2016, which may trigger additional milestone payments from Endo in the future if certain sales milestones are met. BDSI may also be entitled to receive tiered royalties on net sales of BELBUCA that start in the mid-teens.

Based on current operations and forecasts, BDSI estimates that the $50 million dollar milestone payment from Endo, when combined with current cash on hand, provides BDSI with sufficient capital to operate its business to approximately the middle of 2017.

“The FDA approval of BELBUCA is a major milestone for BDSI and a tribute to the exceptional working relationship between the teams at Endo and BDSI. I want to thank all of our employees at BDSI for achieving our third product approval,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.

“BELBUCA will provide a novel, alternative treatment option for millions of people suffering with chronic pain. Clinical trials demonstrated that twice daily administration of BELBUCA was well tolerated and controlled moderate to severe chronic pain. BELBUCA will also provide healthcare practitioners and their patients with a new buprenorphine treatment option. Buprenorphine is a Schedule III controlled substance, meaning that it has been defined as having lower abuse potential than Schedule II drugs, a category that includes most opioid analgesics,” stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI.

Dr. Niraj Vasisht, Senior Vice President of Product Development and Chief Technical Officer at BDSI added, “Our patented BEMA delivery technology has enabled efficient and effective delivery of buprenorphine across the buccal mucosa and the seven approved dosages of BELBUCA will allow physicians to individualize titration and treatment based on the patient’s analgesic needs.”

INDICATION
BELBUCA™ (buprenorphine) buccal film is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.  (More of this release can be found on the web…)

 

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