momentum74

Investors Show Confidence in Cancer Immunotherapy Stocks

VFC any thoughts on DORB.OB ? They just recieved orphan drug status.
finance.yahoo.com/news...

Algae Biofuel Sustainable Markets: Stocks to Benefit

Dont forget about BEHL.PK stock is up huge in the last few months

5 More Stock Briefs

AGEN is in the midst of deciding if they should go to the FDA or not . Quote from today marketwatch/wsj article.
"We're in the midst of deciding whether we should go to the FDA or not, and, if so, what our strategy would be," said Armen

www.marketwatch.com/st...
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Search results for "agen" | Jun. 30 | Search: Save search criteria in new or existing portfolio
Yesterday 10:23 AGEN Hearing positive chatter circulating regarding fast track approval speculation (1.97, +0.13, 7.07%)
25 Jun 2009 07:05 AGEN Expands investigator-sponsored Phase II study of Glioma - filing
- The Brain Tumor Research Center at the University of California, San Francisco, has expanded its P... (1.84, 0.00, 0.00%) more...
17 Jun 2009 07:01 AGEN QS-21 Adjuvant enters Phase III trial of GSK's malaria vaccine
- There are now approximately 15 vaccines containing QS-21 in clinical trials of which four have now... (1.94, 0.00, 0.00%) more... (related GSK )
10 Jun 2009 13:12 AGEN Hearing vague positive chatter circulating on prospects for the Oncophage approval in Europe (2.24, +0.17, 8.21%)
04 Jun 2009 09:24 AGEN Enters debt for equity exchange agreement with Tang Capital - filing dated 6/3
- Antigenics entered into a securities exchange deal with Tang Capital Partners, LP, a holder of an ... (24.90, 0.00, 0.00%) more...
03 Jun 2009 09:51 AGEN Strength attributed to chatter that FDA is set to fast track its kidney drug
- note: on 6/1, Antigenics presented positive Oncophage(R) interim survival data at ASCO. Analysis... (2.18, +0.65, 42.48%) more...
Source tradethenews.com

FDA Calendar Updates: AMAG Pharma, Takeda

Mike What do you think about IGNT ? Keep up the great work. I read everyone of your articles.

FDA Calendar Updates: BDSI, SVNT Deadlines Approach

Mike what do you think about BIEL.PK. Stock was on fire today when they annouced they are filing with the FDA. Looks undervalued but I wanted to know what you think?

FDA Calendar Updates: BDSI, SVNT Deadlines Approach

Mike Harvilla what do you think about BIEL.PK they are applying for FDA CC call on thursday. They are up huge today.


On Jun 15 08:31 AM Mike Havrilla wrote:

> Approval on the way for BDSI's Onsolis:
>
> RALEIGH, N.C., Jun 15, 2009 (BUSINESS WIRE) -- --FDA Action Forthcoming
> BioDelivery Sciences International, Inc. (seekingalpha.com/symbo...)
> today announced that the company has reached agreement with the U.S.
> Food and Drug Administration's (seekingalpha.com/symbo...)
> Division of Anesthesia, Analgesia and Rheumatology Products and a
> multidisciplinary review team on all aspects of the company's New
> Drug Application (seekingalpha.com/symbo...) for ONSOLIS(seekingalpha.com/symbo...)
> (fentanyl buccal soluble film), including the Risk Evaluation and
> Mitigation Strategy (seekingalpha.com/symbo...). Although
> the FDA did not meet its action date of last Friday for this NDA,
> the Division has informed the company that FDA will not be issuing
> a review extension letter as their action on the NDA is forthcoming.
> BDSI received a Complete Response letter from FDA on the NDA for
> ONSOLIS on August 28, 2008, with the only deficiency being the new
> requirement for a REMS. The REMS was not required at the time the
> NDA was originally submitted to FDA in October 2007. The REMS was
> formally submitted to the FDA on December 12, 2008 and the submission
> was placed under a six month review period. "FDA informed us on Friday
> that given how close they are to taking their action, they saw no
> need for issuing a review extension letter, which would have formally
> given them more time to complete their review. In other words, they
> simply need a little more time, which we believe is not inconsistent
> with other recent NDA approvals for other products at the Agency
> where a REMS was required for approval," stated Dr. Mark A. Sirgo,
> President and CEO of BioDelivery Sciences. "We view this as positive
> news, together with the fact that we have reached agreement with
> the reviewing division and the review team on all aspects of our
> NDA, including our REMS. Our dialog and working relationship with
> the reviewing division have been outstanding and have been fundamental
> to the progress we have made in working with them in this significant
> undertaking, to complete the first 'opioid' REMS and the first REMS
> for this Division. We look forward to FDA's forthcoming action,"
> stated Dr. Sirgo. "Although we can not pinpoint the exact timing
> of when the FDA's action might occur, we have previously indicated
> that we expect a first half 2009 approval of the NDA for ONSOLIS.
> Based on our discussion with FDA last Friday, we should be within
> a few weeks of that target." Dr. Sirgo continued, "As it relates
> to BDSI's current financial position, we are pleased to announce
> that over the last several weeks we have received funds from the
> exercise of certain outstanding warrants. The receipt of these funds
> alone should allow us to comfortably manage the company into the
> fourth quarter of this year, including the continued advancement
> of our pipeline, without any additional financing required."

Five Cash-Rich Companies Worth a Look

FMCN is getting takeover chatter in addition too SINA . Huge investor has purchased 28 % of FMCN and could be buying more.
www.tradethenews.com/s...
35 % of FMCN float is short that could give a monster shortsqueeze imo
shortsqueeze.com/?symb...

Alternative Energy Storage: Cheap Will Beat Cool

John Petersen what do you think about CSGH.OB ? I have been watching it drift down and wondering if I should take a bit. They mine for Lithium.