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[kabilius]

Hi all,

Here is a list of approval for the next couple of months.
These dates are NOT final and is subject to change without my control. If I notice the list changes, I will put a note in this thread.

King Pharma (KG) 2009/10/18
GTX Inc (GTXI) 2009/10/30
Transcept Pharam (TSPT) 2009/10/30
Bovie Medical (BVX) 2009/10/31
Hemispherx Biopharma (HEB) 2009-10-31
Cadence Pharma (CADX) 2009/11/13
Lifeline Biotech (LLBO.PK) 2009-11-15
NeurogesX (NGSX) 2009-11-16
Trinity Biotech (TRIB) 2009/11/20
Bovie Medical (BVX) 2009/11/22
iCAD, Inc (ICAD) 2009/11/26
Theravance (THRX) 2009/11/26
Nanosphere (NSPH) 2009-11-30
Dyax Corp. (DYAX) 2009-12-01
Bovie Medical (BVX) 2009-12-03
Somaxon Pharma (SOMX) 2009-12-04 $2.2
Cytomedix (GTF) 2009-12-07
Santarus (SNTS) 2009-12-09
Vion Pharma (VION.OB) 2009-12-12
Spectranetics (SPNC) 2009-12-29

Good luck
kab

[Saintjames]

Good sticky thread here, will try to add to this a bit below

Live FDA Approval Calendar by Crusadernz



Stocks I am holding pending approval:

NEPH - Q4 2009 - Blood filters for kydney dialysis
BIEL - Q4 2009 - ActiPatch Therapy, deliver pulsed electromagnetic field therapy, an anti-inflammatory and pain relief therapy
CTIC 12/01/09 - Pixantrone is for the treatment of non-Hodgkin’s lymphoma (NHL), OPAXIO is for the treatment of non-small cell lung cancer (NSCLC),and ovarian cancer.

And others:

BIIB 11/19/09
MELA 12/4/09
MNKD 1/16/10 - AFRESA, is an ultra rapid-acting insulin
SKYEF.PK 1/31/10
MEDX.OB 1Q09
IGXT.OB 2/10/10 - New dosing option for antidepressant for people with MDD
AMLN 3/05/10
APPA 3/18/10 - Anti nausea medicine for chemotherapy
HGSI 3/21/10
KAMAF.PK 4/2/10
ONTY 2010/2011

If you have more please add them guys...These are hard to keep track of.

[monsieurjean]

IMGG resubmitted additional information (images) to the FDA two weeks ago. I believe the "clock" started ticking again on 10-01-09. Approval is expected within 90 days, i.e. at the latest on Dec. 31st.
On the main IMGG thread there's more posted info. so check it out to see if you are interested in getting in, I personally think the risk/reward ratio is still very good.

Technically (and potentially) IMGG has done well by holding its pps up while waiting for that approval. Best case scenario: IMGG receives FDA approval within the next 6 wks and quickly goes up to $2.50+ on the news and then steadily goes up and waits for a buyout offer of $4.00 from GE, Toshiba, etc.
Worst case scenario: FDA asks for more pictures :( and the pps goes down to .40.
The CEO said recently, "It's not a question of IF but WHEN" for the approval of THIS machine.

Anyway, I'm long on this one and have good feelings about it. I'll probably sell half of my position and ride the rest free on the news....
GTLA

[Dr. Hannibal Lecter]

Add NRI.TO or PINK:NRIFF to the list too. Approval decision is Nov - 4 - 2009. I have been long on this one.
A good link on the product A Not So Extreme FDA Trade: Nuvo Research (TSX:NRI) - BioMedReports.com

[kabilius]

CombinatoRx (CRXX) 2009/11/22 possible

[kabilius]

Hi all,
Biotech isn't doing too well recently, so be cautious about it

Labopharm (DDSS) 2010-02-11
SuperGen (SUPG) 2010-03-08 (I have this one already, and will probably still have it when FDA comes)
A.P.Pharma (APPA) 2010-03-18

[pdtpatrick]

Originally Posted by kabilius Hi all, Biotech isn't doing too well recently, so be cautious about it Labopharm (DDSS) 2010-02-11 SuperGen (SUPG) 2010-03-08 (I have this one already, and will probably still have it when FDA comes) A.P.Pharma (APPA) 2010-03-18

This guy looks poised for some movement. RSI is about to go above 50 and the positive DI is about to cross on ADX. However the current momentum is not that strong so we'll see if volume picks up along the way.

Good luck trading folks.

[kabilius]

POZEN Inc. (POZN) 2010-4-30
Cornerstone Therapeutics (CRTX) 2010-5-15

[pdtpatrick]

If you can, can you please list the dates in US format?

[zippy]

From breakout stocks blog:
FDA plays 2010/02: RPTP AVNR AOLS

A few stocks to buy at dips for anticipated FDA decision. High risk plays.

Raptor Pharmaceutical Corp. (NASDAQ:RPTP)
Current pps: $2.18
During the first quarter of 2010, Raptor plans to meet with the Food and Drug Administration ("FDA") and European Medicines Agency ("EMEA") to discuss plans for a repeat-dose, pivotal, Phase 3 clinical trial in cystinosis patients. Upon receiving FDA and EMEA agreements on protocol, Raptor intends to initiate its Phase 3 clinical trial at multiple sites in the US and Europe. . . more
Cystinosis Research | Raptor Pharmaceutical Corp.
Raptor Pharmaceutical Corp. - Google Finance

AVANIR Pharmaceuticals (NASDAQ:AVNR)
Current pps: $1.74
AVANIR plans to file a full response to the approvable letter in the second calendar quarter of 2010, with an FDA approval decision expected in the fourth calendar quarter.
Drug: Zenvia for patients suffering from PBA
Avanir Pharmaceuticals - Home
AVANIR Pharmaceuticals - Google Finance

Aeolus Pharmaceuticals, Inc. (OTC:AOLS)
Current pps: $0.35
Proposal deadline: February 16, 2010
News jan/12/2010
Aeolus Pharmaceuticals
Aeolus Pharmaceuticals, Inc. - Google Finance

*The data provided here may not be current or accurate and has estimated deadlines which can change anytime. Please do your own research before buying any stocks.