»

[w00tw00t]

Whats going on with BDSI : /

[Kordoyn]

Originally Posted by w00tw00t Whats going on with BDSI : /

It's getting shaken, like HEB is.

[w00tw00t]

its grinding the sky again :p

[mahmissa]

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

[w00tw00t]

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

[Spinner]

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

[kns98]

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

[w00tw00t]

I think that this one will be delayed also.

[ensui67]

Originally Posted by kns98 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.

[GypsyDRB]

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).