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Old 05-25-2009, 01:03 PM   Nav to Top  #11
mahmissa
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Everything I've read says the money maker is the bema tech. I haven't found anything negative yet about bema and I've been proing over the web. The painkiller, Fentanyl, is already on the market. Below article from Zach's, writer predicts an 80% or greater chance of approval.

Coming Soon...

I will look to add more shares this week.
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Old 05-25-2009, 01:10 PM   Nav to Top  #12
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Weird, don't know why the link didn't attach.

Coming Soon...
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Old 05-25-2009, 01:33 PM   Nav to Top  #13
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1. Here is the text of the analyst blog from Zach's since I can't get the link hooked up:

Bet on BDSI's Onsolis Approval
by: Jason Napodano
In April 2009, we are initiated coverage of BioDelivery Sciences International, Inc. (BDSI - Analyst Report) with a Buy rating and a $6 price target. Since that time, the shares are up 35% on investors gaining confidence in the pending approval of Onsolis, a transmucosal fentanyl patch for breakthrough cancer pain. The FDA decision is expected on or before June 12, 2009.

We view the event as a high likelihood of approval (>80% chance). Approval would be a transformational event for BDSI. Not only would it bring about a $30 million milestone payment from worldwide commercialization partner, Meda AB, but BDSI would also receive double-digit royalties (we estimate 20%) on sales of Onsolis upon launch.

The breakthrough cancer pain market is highly competitive, and there are several formulations of fentanyl already on the market, with several more in late-stage development. But we believe that BDSI's BEMA technology offers significant advantages over existing delivery technologies, and could allow for Onsolis to be at least a $250 million peak sales drug.

A $6 price yields a market capitalization of approximately $115 million. This more fairly values the company based on the pending approval of Onsolis. Post-approval, we would not be surprised to see the shares head towards $10 per share due to the dramatically improved financial situation, and the ability it provides for management to now move two pipeline candidates, BEMA Buprenorphine and Bioral Amphotericin B, each with $500 million sales potential, forward in clinical development.


2. Interesting piece on what the FDA is deciding on- the REMS for Onsolis, Risk Evaluation Management Strategy.

BDSI gets good news on drug, though approval is delayed - Triangle Business Journal:


3. I thought this was a helpful post from someone named itsthebusiness/David on Yahoo, for what it's worth. He's been posting about BDSI since September 08.

Background: For those who have not followed BDSI, here is a bit of background: Cephalon has sold a formulation of Fentanyl for breakthrough pain since the mid 1990s called Actiq. At its peak this formulation achieved sales of $700MM. It has gone off patent, although it continues to dominate prescriptions in its generic form. Cephalon introduced a new formulation of Fentanyl in the form of a buccal tablet called FENTORA and now BDSI is close to getting approval for another buccal formulation of Fentanyl to be called ONSOLIS. The principle advantages of ONSOLIS are quicker absorption of Fentanyl and higher concentrations of Fentanyl. This should mitigate the terrible pain of patients quicker and more reliably than any other options, but high concentrations of Fentanyl also pose risks that every investor in BDSI should understand and a frame to understand this risk comes from the experience with FENTORA.

FENTORA was launched in September 2006. In September 2007 the FDA issued a warning about adverse events and even deaths (there were reportedly five) stemming from the use of FENTORA. According to the FDA serious side effects were the result of giving the drug to non-opioid tolerant patients, misunderstanding dosing instructions and inappropriate substitution of FENTORA For Actiq. The FDA emphasized that instructions for use had to be followed exactly. It is for this reason that the FDA has required that companies selling Fentanyl products must have a Risk Evaluation Management Strategy (REMS).

Cephalon has applied for an expanded indication for FENTORA and in its complete response letter the FDA seems to be saying to Cephalon "prove that your REMS works for your current indication in cancer pain before we will approve an expanded indication."

In its complete response letter to BDSI the FDA has required MEDA and BDSI to come up with a REMS for ONSOLIS. Given the experience with FENTORA, I have two conclusions about the REMS:
1. It is a nontrivial requirement. In fact, given the blood plasma concentrations, effective execution of the REMS may be more important with ONSOLIS.
2. It will inhibit sale levels to some extent. About 80 percent of FENTORA sales are reportedly off label and some part of this must be misuse or recreational abuse. By limiting this type of use -- for the important purpose of protecting patient health -- some part of the existent market will be lost. And, the extensiveness of the program will scare away some patients who would really be helped by ONSOLIS.
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Old 05-26-2009, 09:47 AM   Nav to Top  #14
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hmmm....

well this 1-2 week FDA decision delay on HEB has thrown me off on my BDSI play a little.

my next buy point will be in the 5$ - 5.25$ range before June 9th, by then the FDA should release their HEB decision and I will buy the more BDSI shares then.

mahmissa, the Zachs article was in the first post ( i edited it with the quote indent just now) , no need to fret over it

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Old 05-26-2009, 10:33 AM   Nav to Top  #15
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Thanks, Cuse. I start to get a little foggy sometimes:) Was also waiting for HEB to shake out to increase my BDSI position. Ended up talking my hubby into buying a 1000 BDSI shares- hopefully the FDA will give it a thumbs up and he owes me a night out on the town.
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Old 05-26-2009, 08:16 PM   Nav to Top  #16
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Originally Posted by lattes View Post
So sitting and talking about the company with an guy who works with me got me thinking. BDSI could be a multi-billion dollar company but you have to go LONG on it.

Here is my thinking behind it. The fastest way to get a drug into you is intravenous, the second fastest is through mucus membranes (Why people snort cocaine)

Taking a drug in pill form is actually terribly inefficient as well as slow.

An opiate in film form would not only be prescribed to cancer patients as some are speaking about but would end up getting a lot of 'off label' use in pain patients etc.

So here is the thinking about it being a multi-billion dollar company.

If in three years from now there are 20m scripts written per year for these at 50 strips average per script and BDSI is seeing $1 from each of them... well that is $1b right there.

Current market cap is $100m, that means that the company really does have a chance of being a '10 bagger'

Please someone shoot me down here if I am way off on anything.
I'd think that chronic pain patients will use pills more often since absorption is slower. It's what you'd want, a time released dose unless you're in it for the high. If that's the case this patch was the best thing ever invented. XD

This patch is being marketed as useful "in conditions where rapid delivery of drug is important, oral dosing is not optimal, or where intravenous lines or injections are unavailable or not practical."

It's more likely that the medics in hospitals/for home use will use conventional methods but it'll be nice to have this patch as an option.

I could see this being used by the military on the field. Slap one in the cheek of a wounded soldier. That'd be something.
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Old 06-02-2009, 10:49 PM   Nav to Top  #17
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nice jump today...

can't find any news on why though...oh well, ill take it
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Old 06-03-2009, 12:25 AM   Nav to Top  #18
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I was trying to find some news for the jump today and although i couldn't find any news for today, i did come accross these articles.

just a little more info about BDSI, BEMA and thier drugs.




Article : Delivery Firms Focus on Efficiency & Efficacy Genetic Engineering & Biotechnology News - Biotechnology from Bench to Business

Niraj Vasisht, Ph.D., vp, product development at BioDelivery Sciences (BDSI), described BDSI’s delivery platforms including its Bioral™ oral delivery system and its BioErodableMucoAdhesive (BEMA™) technology.
The company’s first drug candidate using Bioral technology for oral delivery of the antifungal agent amphotericin B (Bioral Amphotericin B) entered Phase I trials last year. The company reported initial results in February that identified doses that were well tolerated with no meaningful changes in laboratory safety values. Plasma concentrations of amphotericin B were comparable to those seen in prior animal toxicology studies using the same formulation, according to Dr. Vasisht.
Bioral technology encapsulates a drug in a lipid crystal to allow its oral administration. Alternating layers of lipids spiral around a drug molecule, potentially protecting it from degradation by acid or digestive enzymes in the stomach.
According to BDSI, unlike other technologies, Bioral protects the drug without chemically bonding to it, can be used for a wide variety of drugs, and facilitates oral delivery of drugs that currently require intravenous administration.
The company’s lead product, Onsolis™ (fentanyl buccal soluble film), consists of a small, dissolvable polymer film formulated with the opioid analgesic, fentanyl.
Applied to the buccal lining of the cheek, Dr. Vasisht said that BEMA technology delivers a dose of the drug quickly, and that Onsolis can manage breakthrough cancer pain in patients already receiving opioid treatment for underlying persistent cancer pain. Biodelivery Systems’ NDA for Onsolis is currently under late-stage review by the FDA.

A second product utilizing the BEMA drug delivery technology, BEMA Buprenorphine, is also under clinical development for various pain conditions.




Breakthrough Cancer Pain Meets Its Sticking Point

Breakthrough Cancer Pain Meets Its Sticking Point | IRGnews

“Breakthrough pain” (BTP) is a common, debilitating feature of chronic pain that frequently afflicts cancer patients. While persistent, or continuous, pain can usually be controlled through a patient’s normal oral pain medication regimen, breakthrough pain literally “breaks through” regular doses of pain medication.

Breakthrough pain can be sudden in onset and the pain very severe. If untreated or treated inadequately, BTP is often a disabling problem for patients with cancer. It can have a significant negative impact on physical functioning, psychological well being, and sleep. In addition, patients with cancer-related BTP are more likely to have pain-related hospitalizations and emergency room visits than patients without BTP.

Developed by Raleigh, North Carolina-based BioDelivery Sciences International, Inc., Onsolis™ is an opioid analgesic currently under review by the FDA for the potential management of breakthrough pain in cancer patients who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Onsolis utilizes the BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film that is applied to the buccal membranes, or inner cheek lining. The film is specially designed to adhere to the inner cheek within seconds, bioerodes within fifteen to thirty minutes, and is designed to optimize fentanyl delivery across the mucous membranes.

While there are two fentanyl breakthrough cancer pain products already on the market—one a fentanyl lozenge, the other an effervescing tablet—the delivery system for Onsolis makes it unique. BEMA delivery technology may offer more convenience, be harder to misuse, and cause little irritation to the inside of the mouth. Onsolis has undergone two Phase III clinical trials in opioid tolerant adult cancer patients experiencing breakthrough cancer pain, and is currently not approved for use; if approved by FDA, Onsolis will be commercialized in the U.S. by Meda Pharmaceuticals.

“Many cancer patients that are already following a course of opioid analgesics do not understand why they still may be experiencing periodic sharp spikes in pain,” said Dr. Richard L. Rauck, Executive Director of the Carolinas Pain Institute and for the Center for Clinical Research, a center that participated in the Phase III trials for Onsolis. “Cancer patients with this kind of pain should discuss various options with their treating physician. These patients might someday benefit from a product like Onsolis.” Visit BioDelivery Sciences International (NASDAQ: BDSI) | IRGnews to learn more.
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Old 06-03-2009, 11:12 AM   Nav to Top  #19
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Looks like I might have missed this one. Anyone have a good entry target to watch for?
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Old 06-05-2009, 03:06 AM   Nav to Top  #20
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I'm not expecting much of a retrace prior to the June 15 deadline, maybe back to the 5.6 range. I got in around around there and have a stop set not to far below that.

I think a lot of the approval is already baked into the current price, thus not expecting a skyrocket with the approval (might even see a sell the news drop if we continue to run up the next week or so), nonetheless I think it is a nice long term hold, for many of the reasons already stated in this thread, and if they get the approval, regardless of the short term pps affect, the guranteed cash inflow will make this a winner.

If you really want in, I'd try to catch a dip around 5.8 to 5.85
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