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-   -   Buy: BDSI - FDA approval date June 15th (http://www.stockrants.com/forum/stock-picks/929-bdsi-fda-approval-date-june-15th.html)

Cuseabuse04 05-20-2009 11:19 PM

BDSI - FDA approval date June 15th
 
Hey all,

This is my first attempt at posting a stock pick and it's another pharma company expecting a drug of theirs to be approved by the FDA. I have been in HEB since .80 cents and have seen what a ride that has been.

BDSI doesn't seem to have the same risk/reward as HEB does, but it seems this has a more certain chance of FDA approval (80%, whatever that means). The PPS currently is at 5.56 as of the close on 5/20. Word is it would be worth at least 10/share pending approval. As you will see, other StockRants members have put more research into this company and see a huge potential not with the drug, but with the new way of drug intake (BEMA TECH) they are developing (potential of Billions). And with that in mind this would be a fantastic LONG play as well

Zachs.com (don't know how reputable they are, but it was a posted link on the finance.google page for the stock) recently came out with an article that can explain the company's drug situation better than I can. Here is a copy of the article:
Quote:

In April 2009, we are initiated coverage of BioDelivery Sciences International, Inc. (BDSI) 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.
Bet on BDSI's Onsolis Approval


Personally, since I'm a newbie to the stock market, I don't know how to get an expert read on a company's financial situation, and how that would effect the risk with picking this stock. I just think the stock will continue to rise just on hype and anticipation (obviously not with the same volatility we saw with HEB), and it could be a solid play for 20% gains pre-approval, and 100% gains post approval.

I'm going to buy 20% of what I plan to invest in total with the stock tmrw, and I will wait til after HEB's FDA decision to purchase the other 80% of what I plan to hold. I think if HEB doesn't get approved it will cause a ripple effect with the other pharma stocks expecting a FDA decision soon, and therefore allow for a lower pps on BDSI. If HEB gets approved, I'll be taking my profits from there and moving them straight to BDSI.

Anyways, I don't know how informative of a post that was, but I hope it gives you guys the opp. to check it out for yourselves and see if its worth the dive.

Piccooar mentioned this stock earlier in a thread about future FDA approval dates, but I felt the stock needed it's own thread. credit goes to piccooar for finding this.

It goes without saying this is clearly just a spec play and you should only invest the money you can afford to lose.

Kordoyn 05-20-2009 11:59 PM

Bought in at 5.45 or so, and I'm all just coasting for now. Not too much daily movement, although nothing is quite as exciting as HEB. What attracted me to this company more so than the pending Onsolis FDA approval was their BEMA technology license.
It's a new delivery system for drugs, works kind of like a nicotine patch, but adheres to the inside of your cheek, and slowly disolves. Apparently they can make a patch like this for all sorts of drugs, so even if this FDA decision falls through not all is lost.


They have a partnership for funding lined up upon approval with AB Meda to the tune of $30 million, so expect a nice pop in price upon approval, and steady gains afterward if they can expand on their BEMA platform.
The market for Onsolis itself is a little weak IMO, it's an opiate painkiller, and there are dozens of generics out there for cancer patients. It's the BEMA delivery that makes this play interesting.

http://www.socialpicks.com/ideas/show/241292

BioDelivery Sciences International | BEMA Technology

Mendy 05-21-2009 12:22 AM

From a quick glance at this company they have not been above 6.05 since they went public...I don't find the risk reward to be worth the trade at this point in time...We might see a run up closer to the date of approval but I would be cautious of buying the top here...

Kordoyn 05-21-2009 12:29 AM

Quote:

Originally Posted by Mendy (Post 7113)
From a quick glance at this company they have not been above 6.05 since they went public...I don't find the risk reward to be worth the trade at this point in time...We might see a run up closer to the date of approval but I would be cautious of buying the top here...

True, but this is their first product going to market as far as I can tell. They have been running on research money and test results.
Not to mention only 19m shares, and guaranteed non dilutive funding upon approval.

It has potential to get interesting if the FDA is feeling kind.

Kordoyn 05-22-2009 04:04 PM

Quote:

Originally Posted by lattes (Post 7860)
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.



My thinking was along the same lines as yours. Really this particular drug is just the beginning of what could be a huge development. Basically any drug that is taken in pill form could potentially be made into a patch like this with royalties going to BDSI. Even stuff that is normally taken IV might be easier and safer to administer this way, unless it's a critical emergency.

I like the pull back today, as soon as HEB sorts things out I'll be able to get my hands on more BDSI and several other companies I've been eying.

reddy 05-22-2009 07:40 PM

OK
 
I see that people are already onto BDSI...I was going to recommend a buy on it myself...Very nice company and has very good potential....but i can get in only if HEB turns out my way...wait for me...

mahmissa 05-22-2009 07:55 PM

I also agree that the Bema tech is the seller here, no the painkiller itself. Oral dose painkillers can take 1-3 hours to be fully effective. This method of ingestion is almost immediate.

One of the biggest side effects for people undergoing chemotherapy is intense nausea, which makes swallowing a painkiller difficult, and opiates generally need to be taken with food or can cause damage to the stomach lining. This ingestion method may ameliorate that.

By the way, so excited a stock I mentioned in another forum got some discussion here- makes me feel better about owning this:)

Kordoyn 05-23-2009 12:03 AM

Quote:

Originally Posted by mahmissa (Post 8027)
I also agree that the Bema tech is the seller here, no the painkiller itself. Oral dose painkillers can take 1-3 hours to be fully effective. This method of ingestion is almost immediate.

One of the biggest side effects for people undergoing chemotherapy is intense nausea, which makes swallowing a painkiller difficult, and opiates generally need to be taken with food or can cause damage to the stomach lining. This ingestion method may ameliorate that.

By the way, so excited a stock I mentioned in another forum got some discussion here- makes me feel better about owning this:)

'Ameliorate'. Nice.

mahmissa 05-24-2009 08:27 AM

What can I say? An undergrad degree in English is helpful for some things, lol.

Aaron 05-25-2009 12:33 PM

Quote:

Originally Posted by Kordoyn (Post 8069)
'Ameliorate'. Nice.

i concur... good verbage. :D


i like the innovation :) lets tackle this one!

i'm gonna put this on my watch list \0-0/


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