Tax Season is Here! Save 15% on H&R Block Online
iconAll times are GMT -4. The time now is 06:47 PM. | Search:

» StockRants Stock Forum » Public Stock Forums » US Stock Picks » Buy: BDSI - FDA approval date June 15th



Reply
 
Thread Tools Search this Thread
Old 06-09-2009, 09:43 AM   Nav to Top  #41
w00tw00t
Senior Trader
 
w00tw00t's Avatar
 
Join Date: Jun 2009
Location: Genk
Posts: 160
Rep Power: 0
Reputation: 744
w00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to behold
Default

Whats going on with BDSI : /
w00tw00t is offline   Rate this post Yes | No Reply With Quote
Old 06-09-2009, 09:46 AM   Nav to Top  #42
Kordoyn
UberTrader
 
Kordoyn's Avatar
 
Join Date: May 2009
Location: TOronto
Posts: 383
Favorites: DOW TCK HEB
Rep Power: 277
Reputation: 3456
Kordoyn has a reputation beyond reputeKordoyn has a reputation beyond reputeKordoyn has a reputation beyond reputeKordoyn has a reputation beyond reputeKordoyn has a reputation beyond reputeKordoyn has a reputation beyond reputeKordoyn has a reputation beyond reputeKordoyn has a reputation beyond reputeKordoyn has a reputation beyond reputeKordoyn has a reputation beyond reputeKordoyn has a reputation beyond repute
Default

Originally Posted by w00tw00t View Post
Whats going on with BDSI : /
It's getting shaken, like HEB is.
Kordoyn is offline   Rate this post Yes | No Reply With Quote
Old 06-09-2009, 10:34 AM   Nav to Top  #43
w00tw00t
Senior Trader
 
w00tw00t's Avatar
 
Join Date: Jun 2009
Location: Genk
Posts: 160
Rep Power: 0
Reputation: 744
w00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to behold
Default

its grinding the sky again :p
w00tw00t is offline   Rate this post Yes | No Reply With Quote
Old 06-10-2009, 03:18 PM   Nav to Top  #44
mahmissa
UberTrader
 
mahmissa's Avatar
 
Join Date: May 2009
Location: Washington
Posts: 294
Favorites: BAC, HEB, LVS
Rep Power: 232
Reputation: 2450
mahmissa has a reputation beyond reputemahmissa has a reputation beyond reputemahmissa has a reputation beyond reputemahmissa has a reputation beyond reputemahmissa has a reputation beyond reputemahmissa has a reputation beyond reputemahmissa has a reputation beyond reputemahmissa has a reputation beyond reputemahmissa has a reputation beyond reputemahmissa has a reputation beyond reputemahmissa has a reputation beyond repute
Default Insiders selling shares

Granted, half the shares are held by insiders, but why would they sell some now if approval is around the corner?

BDSI: BIODELIVERY SCIENCES INTL IN Insider Transactions
__________________
Mahmissa

May you live all the days of your life- Jonathon Swift

Last edited by mahmissa; 06-10-2009 at 03:34 PM..
mahmissa is offline   Rate this post Yes | No Reply With Quote
Old 06-10-2009, 03:33 PM   Nav to Top  #45
w00tw00t
Senior Trader
 
w00tw00t's Avatar
 
Join Date: Jun 2009
Location: Genk
Posts: 160
Rep Power: 0
Reputation: 744
w00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to behold
Default

Insiders selling bit by bit is not uncommon. Keeps the price stable. If they sell large amounts after approval they would scare the sheeps. IMO
w00tw00t is offline   Rate this post Yes | No Reply With Quote
Old 06-11-2009, 06:43 PM   Nav to Top  #46
Spinner
Untitled
 
Spinner's Avatar
 
Join Date: May 2009
Location: Vancouver
Posts: 89
Favorites: BA, SSW, HEB
Rep Power: 212
Reputation: 2155
Spinner has a reputation beyond reputeSpinner has a reputation beyond reputeSpinner has a reputation beyond reputeSpinner has a reputation beyond reputeSpinner has a reputation beyond reputeSpinner has a reputation beyond reputeSpinner has a reputation beyond reputeSpinner has a reputation beyond reputeSpinner has a reputation beyond reputeSpinner has a reputation beyond reputeSpinner has a reputation beyond repute
Default

Ya know what, I'm just going to go ahead and bump this thread as a reminder that BDSI's supposed FDA decision date is this coming Monday, so tomorrow (Friday) is potentially the last day of pre-approval trading.

Yes, yes, we've all got HEB fatigue and know this might stretch on into another month of tedious soap opera, but the FDA may well surprise us and pop a decision tomorrow on Onsolis.

BDSI up in after hours, $6.44. Expect significant movement and manipulation tomorrow.

Beware the HEB blinkers!

Cheers, Spinner
__________________

DIsclaimer: Spinner is not a genius trader, terrible results speak for themselves. However, in the spirit of complete disclosure, he is holding the following stocks long for dividends (SSW, BA), trading the following stocks for growth (OCNF, HEB, BDSI, CTIC, NRI, ICAD), and holding the following loony tunes penny shares for the million dollar payday (BIPH, XDSL).
Spinner is offline   Rate this post Yes | No Reply With Quote
Old 06-11-2009, 06:59 PM   Nav to Top  #47
kns98
Senior Trader
 
kns98's Avatar
 
Join Date: May 2009
Location: new york
Posts: 103
Favorites: GNTA CTIC ADLS
Rep Power: 141
Reputation: 358
kns98 is just really nicekns98 is just really nicekns98 is just really nicekns98 is just really nice
Default

I dont kow if anyone has said this but fentanly is only administered to the sickest of patients. it is very ez to OD on it cause death by respiratory depression.

I doubht fentanly has a large market but i dont know then numbers. Also FDA will be VERY VERY wary of safety issues on this one.

GLTA
kns98 is offline   Rate this post Yes | No Reply With Quote
Old 06-11-2009, 07:40 PM   Nav to Top  #48
w00tw00t
Senior Trader
 
w00tw00t's Avatar
 
Join Date: Jun 2009
Location: Genk
Posts: 160
Rep Power: 0
Reputation: 744
w00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to beholdw00tw00t is a splendid one to behold
Default

I think that this one will be delayed also.
w00tw00t is offline   Rate this post Yes | No Reply With Quote
Old 06-11-2009, 09:06 PM   Nav to Top  #49
ensui67
Trader
 
ensui67's Avatar
 
Join Date: May 2009
Location: new york city
Posts: 33
Favorites: gnta nvda sqnm
Rep Power: 140
Reputation: 380
ensui67 is just really niceensui67 is just really niceensui67 is just really niceensui67 is just really nice
Default

Originally Posted by kns98 View Post
I dont kow if anyone has said this but fentanly is only administered to the sickest of patients. it is very ez to OD on it cause death by respiratory depression.

I doubht fentanly has a large market but i dont know then numbers. Also FDA will be VERY VERY wary of safety issues on this one.

GLTA
Fentanyl - Drug information from Medic8.com

Fentanyl is usually administered to opioid-tolerant patients because the lethal dose has not been determined. It is the most potent opiate in alleviating cancer pain and the opiate of choice for those cases. If it was easy to overdose on this patch it would not have passed Phase I (safety) clinical trials.
ensui67 is offline   1 thumbs up / 0 thumbs down. Rate this post Yes | No Reply With Quote
Old 06-11-2009, 09:35 PM   Nav to Top  #50
GypsyDRB
UberTrader
 
GypsyDRB's Avatar
 
Join Date: May 2009
Location: Charlotte
Posts: 213
Favorites: HEB, NEPH, BAC
Rep Power: 225
Reputation: 2357
GypsyDRB has a reputation beyond reputeGypsyDRB has a reputation beyond reputeGypsyDRB has a reputation beyond reputeGypsyDRB has a reputation beyond reputeGypsyDRB has a reputation beyond reputeGypsyDRB has a reputation beyond reputeGypsyDRB has a reputation beyond reputeGypsyDRB has a reputation beyond reputeGypsyDRB has a reputation beyond reputeGypsyDRB has a reputation beyond reputeGypsyDRB has a reputation beyond repute
Default

I would like some perscribed for compassionate use. I suffer from HEBiphlia - a somewhat common, very painful disease seen a lot in these parts.


---here commences something useful in this post----------

as reported by Mike Havrilla from biomedreports.com

BioDelivery Sciences (NASDAQ:BDSI) has a pending Onsolis (BEMA fentanyl) NDA resubmission for the proposed treatment of breakthrough cancer pain through a small, dissolving polymer delivery system for the opiate painkiller fentanyl designed for quick absorption through the cheek. On 12/15/08, BDSI announced in a press release that the FDA requested conversion of the originally submitted risk minimization action plan (RiskMAP) to a Risk Evaluation and Mitigation Strategy (REMS) and informed the Company that all other aspects of the NDA review were complete.

Given this information, the prospects for Onsolis approval appear excellent, with an approval decision possible as early as Friday 6/12/09 or the following Monday based on a Class II (six-month) review by the agency on the resubmission of the required REMS by BDSI. In the same press release, BDSI provided guidance for expected approval of the Onsolis approval during the first half of 2009.

Earlier this year, BDSI raised $6M in cash from partner Meda AB (STO:MEDAA) ($2.3B U.S. Dollar market cap) from a $3M expanded marketing agreement (which includes all countries except Taiwan and South Korea) and a $3M advance of the $30M milestone payment triggered by FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents about 22% of the Company's current market cap of $123M, in addition to double-digit royalties that will be received on product sales, an additional $30M possible in sales-related milestone payments, and a $5M milestone payment that is due upon EU approval/launch.

While I do not typically hold small and micro-cap bio-med stocks through binary events such as FDA decisions and clinical trial results, BDSI is an exception for me and the Company expects to generate positive operating cash flow this year if Onsolis is approved. Also, the Company is debt free with a promising mid-stage pipeline based on its drug delivery technology platform that can be funded through milestone payments and royalties from Meda AB (which expects peak sales exceeding $200M for Onsolis).

Last edited by GypsyDRB; 06-11-2009 at 09:48 PM..
GypsyDRB is offline   1 thumbs up / 0 thumbs down. Rate this post Yes | No Reply With Quote
Reply

Tags
BDSI, BEMA, FDA, HEB, onsolis

Similar Threads
Thread Thread Starter Forum Replies Last Post
Buy: HEB - FDA APPROVAL May 25th - 2000% gain possibility StocksHaven US Stock Picks 11 05-10-2009 03:00 PM
(UK) Week Ahead - 11th-15th May, company earnings reports inspirational Rumors & News 1 05-09-2009 05:31 PM
ANTIGENICS INC get FDA Approval ScottG Rumors & News 2 04-29-2009 09:48 AM


Thread Tools Search this Thread
Search this Thread:

Advanced Search

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is On