icon

BioDelivery Sciences (BDSI) announced this week that the primary endpoint for its recently-completed Phase III BEMA Bup trial was missed, although some results were encouraging enough to spur the company to look towards conducting another efficacy trial that will run approximately nine months from its start date.

Dr. Andrew Finn, Executive Vice President of Product Development at BDSI, stated that, "We observed significant efficacy in the opioid experienced subset of patients and believe there is a clear pathway forward to determine the same in the opioid naive patients. We are also pleased to see that the product was well tolerated and that no unexpected side effects were seen. Our overall evaluation of the data in these two patient populations has given us valuable insight and confidence that we will use in commencing a new study."

Additional comments made by BioDelivery's President and CEO, Dr. Mark A. Sirgo, reiterate the positive belief of the company that BEMA Bup for the indication of chronic pain has not been derailed, just delayed.

BDSI has dropped to the three dollar mark of late, and it's possible that this latest delay will add some additional downward pressure.

As preparations for another trial gain traction, however, investors will be looking at other short and long term catalysts for the company.

Onsolis, a treatment for breatkthrough pain in cancer patients, is expected on the Canadian market this quarter, while negotiations with the FDA over the REMS issues relating to the product in the United States should be winding down.

A commercial launch that is quick to gain traction in Canada, combined with a positive resolution to the REMS issues in the US, could offset any negative sentiment that might result from the latest trial news, but for the time being investors could expect some short term volatility, as testified by the recent price drop.

BioDelivery and BEMA both continue to hold significant long term potential, in my opinion, but the best returns might still be a while away.

Keep an eye on comments from the company about its short and long term plans. It's possible BDSI and its technology could be scooped up by a larger pharma for a dirt cheap price.

Of note, BioDelivery's Onsolis partner is Meda.

Disclosure: Long BDSI.

8 Comments

  1. Gravatar
    jeenBota Mar 25, 2012

    Look at these video-interview with medical practitioners which came with DARADIA with regards to learning discomfort management. Some medical doctors eventually handed down FIPP in addition buy tramadol online The particular Us School with Pediatrics can be a professional corporation devoted to medical, protection, plus well-being of little ones, small children, adolescents, in addition to the younger generation. Consequently, it has the committees develop rules, postures, along with software programs to compliment a vision of your company. The AAP tips pertaining to discomfort supervision consider with the techniques listed below.

  2. Produces endorphins, feel great bodily hormones. buy vicodin online Eating habits study studies plus expertise in PEMF fight for a wider benefits of PEMF therapy approaches to medical apply.Therapy for cuboid pathologies, nerve and attache regeneration, ache, as well as infection provides instigated homework to the essential apparatus with actions

  3. Gravatar
    deondids May 19, 2012

    Sci buy ambien internet The individuals slumbering human brain account activation stage is actually primary decided so that you an kind some sort of maangement as well as 'baseline' to assess from <>6

  4. Gravatar
    jeemboIllirm May 23, 2012

    If the synthetic ingredients were not included, it could have earned a higher pharmacological rating buy adderall Never hammer on the replacement pieces

  5. Gravatar
    jeemboIllirm May 23, 2012

    You also can have mental abundance buy adderall online With the financial statement forecast, this section also provides intrinsic value of the company by using Net Asset Valuation method

  6. Gravatar
    juderilels May 25, 2012

    This kind of being reported, there exists one particular record regarding 5-HT 2A antagonists improving upon detained match up to set efficiency ( Terry et , 2004 ) generic soma For example, a player could trust in sleeping and also a proper dieting so that you can carry out his / her top in a forthcoming activity, while somed sort of employee can easily boost in addition to strengthen his or her mental capabilities by means of nutritious behaviot in addition to health and fitness

  7. Gravatar
    kainFees May 25, 2012

    Follow alp instructions fteo oyuracupuncturist to get the otmil result fron the treatment order soma Almsot evertyhing now isdesinged with all the huamn body in miund

  8. Gravatar
    sonataErar May 27, 2012

    5-6 months of filter life - based on 20 litres peer day buy oxycontin In the past the furniture was made conveyed the message of ritual and the past

Add a Comment