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Old 07-14-2009, 08:58 PM   Nav to Top  #111
patch
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Haven't seen any posts on this in a while. I'm still long on this, and thinking of picking up some more shares. How low do you think this can go? Possibly all the way down to $5?
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Old 07-16-2009, 12:24 PM   Nav to Top  #112
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BDSI has received FDA approval !!! up 13% already
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Old 07-16-2009, 12:43 PM   Nav to Top  #113
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RPT-BRIEF-U.S. FDA says approves Aveva's Onsolis for cancer | Markets | Markets News | Reuters

Thats the link to support JBVet1's comment
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Old 07-16-2009, 12:48 PM   Nav to Top  #114
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Sorry about that, I actually was unable to find a link just saw it on the scottrade streaming news and the price shot up. Thanks for adding the link
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Old 07-16-2009, 01:07 PM   Nav to Top  #115
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Was expecting this to go up a few dollars, and not just 50 cents. This is still below my purchase price. I guess I will hold on to it for a few more days and see what happens. If a spike, I'll sell it off. If a gradual climb up, I'll wait.

How is everyone else going to play this approval?
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Old 07-16-2009, 01:11 PM   Nav to Top  #116
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was also expecting a bit more of a boost. I've got a couple thousand shares in both my TDA and IRA accts...will hold for 2-3 weeks and then look to decrease my position regardless. If this is getting manipulated right now that should sort itself out over the next few weeks hopefully.
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Old 07-16-2009, 01:59 PM   Nav to Top  #117
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This is the official company press release

BioDelivery Sciences and Meda Announce FDA Approval of ONSOLIS - Yahoo! Finance

RALEIGH, N.C.--(BUSINESS WIRE)--BioDelivery Sciences International, Inc. (Nasdaq: BDSI - News) and Meda AB today announced approval from the U.S. Food and Drug Administration (FDA) to market ONSOLIS™ (fentanyl buccal soluble film), formerly referred to as BEMA™ Fentanyl, for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. ONSOLIS is the first product to utilize the company’s proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek).


“The approval of ONSOLIS is a landmark and transformational event for BDSI and represents the culmination of an extraordinary and focused effort by a determined group of BDSI and Meda employees,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences. “All of us at BDSI, along with our partner Meda, are very pleased to provide healthcare practitioners and their patients suffering from breakthrough cancer pain with a new treatment option for this serious and debilitating condition.”

“Importantly, with the approval of ONSOLIS, we have validated the utility of the BEMA drug delivery technology and demonstrated our ability to move a product through clinical development and the regulatory requirements set by FDA,” said Dr. Andrew Finn, Executive Vice President of Product Development. “We now look forward to replicating our performance and regulatory achievements as we progress our pipeline.”

“Having worked on the clinical development of ONSOLIS, it is exciting to see it reach approval,” said Dr. Richard L. Rauck, Executive Director of the Carolinas Pain Institute and for the Center for Clinical Research, a site that participated in the Phase 3 trials for ONSOLIS. “Many patients with cancer suffer from these sharp spikes in pain referred to as breakthrough pain. These patients can benefit from a product like ONSOLIS with its onset of action and oral tolerability profile. We look forward to having this important option available for our patients with cancer breakthrough pain.”

ONSOLIS is anticipated to be available in the fourth quarter of 2009 and will be commercialized in the U.S. by Meda Pharmaceuticals, the U.S. subsidiary of Meda AB. Meda is the company’s commercialization partner for the product worldwide, with the exception of Taiwan and South Korea, the rights to which remain with BDSI. “We are very excited to launch ONSOLIS in the U.S. and make this product available to patients and healthcare providers,” said Anders Lonner, Chief Executive Officer of Meda AB. “The introduction of ONSOLIS has high priority for us, and we are well positioned to be successful.”

Under the terms of its commercialization agreement with Meda, BioDelivery Sciences will receive an aggregate of approximately $27 million in milestone payments. The first is based upon FDA approval of ONSOLIS which is in the amount of approximately $12 million. Meda had already advanced the company $3 million in January 2009 against the $15 million milestone payment. A second payment of $15 million will be received following the manufacture of launch stocks of ONSOLIS, a target the company has also achieved. In addition, BDSI will receive a double-digit royalty on net sales as well as the potential for up to another $30 million in milestone payments upon the achievement of certain sales thresholds.

“We are also announcing launch of the FOCUS™ (Full Ongoing Commitment to User Safety) Program for ONSOLIS, the first opioid Risk Management and Evaluation Strategy (REMS),” said Dr. David Wright, Director of Regulatory Affairs at BDSI. “The goal of the FOCUS Program for ONSOLIS is to mitigate the risk of ONSOLIS overdose, abuse, addiction, and serious complications due to medication errors. The program was created in accordance with the FDA’s requirements to help ensure that the benefits outweigh the risks of ONSOLIS. The program will facilitate appropriate use of ONSOLIS and provide healthcare practitioners, patients, and caregivers support through training and education.”

BDSI will hold a webcast to discuss the approval of ONSOLIS on Friday, July 17, 2009 at 10:00 a.m. Participants are invited to access the live webcast or obtain a dial-in number from the company’s website at BioDelivery Sciences International.
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Old 07-16-2009, 02:43 PM   Nav to Top  #118
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I also have shares in HEB. I wondering if this same thing will happen if HEB ever gets their approval.
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Old 07-16-2009, 05:38 PM   Nav to Top  #119
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Originally Posted by patch View Post
I also have shares in HEB. I wondering if this same thing will happen if HEB ever gets their approval.
I doubt it. The thing that's important with BDSI's approval isn't fentanyl, which has been around for a while, but the buccal mucosa path itself. Onsolis is going to have plenty of competition so it's not nearly as breakthrough a drug as Ampligen would be for CFS, a disease the medical community has only recently legitimated in consensus, and which would have absolutely no competition.

I've got BDSI as well and am disappointed. We'll see what the next few days hold. Might have to go long to wait for marketing results. If abusers made money this drug would make us a fortune. (Irony intended no flames thanks).
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Old 07-17-2009, 01:29 AM   Nav to Top  #120
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Just want to make the BDSI shareholders aware of the press call this morning (it is already morning in my country).
If I m not mistaken its an hour after the opening of the stock exchange, so at 10 o'clock.

And a newly released article, see Congratulations BioDelivery Sciences Longs! -- Seeking Alpha, explaining why BDSI did not hit the 10 dollars.

D-Day was Thursday for BioDelivery Sciences (BDSI) as the FDA finally granted approval to market and distribute Onsolis, a treatment for pain in cancer patients.

The FDA delayed issuing the Onsolis approval for over a month; a time frame that saw the BDSI stock slide from eight dollars to six. Some investors, myself included, were sceptical of the actions of the FDA and others were turned off by the large amount of insider sales after the delay was announced mid-June.

The combination of investor skepticism and insider selling took the wind out of BDSI's sails and the stock closed the day on approval day a mere 2.5% to the positive, although it did hit $7.25 at one point during afternoon trading.

Many predictions, mine included, had the stock trading as high as between $10-$12 after approval before settling into the $8-$10 range, but that was before things started to look suspect in late June.

Long term investors who hung in there waiting for a nice spike after approval were quite disappointed yesterday, but there's no reason to worry or panic sell now because the stock will rise again; it's just a matter of time.

In fact, with the Onsolis approval now a done deal, I see BDSI as a BUY while trading for $6.

Today's recessionary market is not a normal one. The stocks of both Antigenics (AGEN) and Epicept (EPCT), for instance, both actually traded down when they received market approvals over the past year (Oncophage in Russia for AGEN and Ceplene in Europe for EPCT). Their situation, in my opinion, created great buying opportunities for those who have the patience to load up low and wait. AGEN has already began to come back and I don't think there is any doubt that BDSI will, too.

There's no telling why the stock traded as it did today, we can only speculate. Those who saw the news of approval ready to hit the wires probably shorted at the $7.25 high, and it could be that some of the insiders that sold now want back in. Both scenarios would indicate that the big boys will play this stock to suit their needs until their positions are set and the real move can begin.

The small investor should not fall prey to the games of the big boys. Hold onto your shares and wait for the stock to rise. With Onsolis approved, a revenue stream is all but guaranteed- and that's on top of the $27 million milestone payment that the company will now receive.

Something that investors may find troublesome is the fact that the Onsolis approval came with some FDA restrictions in order to keep patients from overdosing or becoming addicted to the drug. Labels such as this one can scare away potential customers, and therefore hurt revenue, and some may have altered their value of potential future drug sales based on these FDA restrictions. That may be another reason why a spike to above $10 did not occur.

Additionally, investors who were counting on Michael Jackson's Doctors getting a hold of Onsolis to increase distribution will undoubtedly be disappointed with the recent heat being brought on prescription medications.

All being said, I know the price action yesterday did not indicate it, but it is a day for shareholders of BDSI to celebrate. HOLD onto your shares. While the stock may be volatile for a little bit longer, with an FDA approved drug and a potentially blockbuster delivery system, BioDelivery is a much safer investment on Thursday than it was on Wednesday.

I did not sell today; I'm going to wait for the eventual rise in price before I sell any shares. As I've described before, I'm playing on house money with this one.

Last edited by Frederick; 07-17-2009 at 01:34 AM..
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