Watch Food / drug approval decision dates

kabilius · 06-06-2009, 09:04 PM

Hi all,

I found this online yesterday and thought I'd share this with you all. (since there are a lot of biotech buyers here)

Calender of expected U.S. food and drug administration approval decisions
Following are the contributors: schwi105, ttnt111, fas917, w00tw00t, Ingwe, mahmissa, spacepenguin, Sharpie
List is updated on June 15th, 2009

HEB – May 25th, 2009
NEPH.OB - June 13th, 2009
SVNT – June 16th, 2009 (drug to be reviewed by Arthritis Advisory Committee appointed by the FDA)
BDSI – June 15th, 2009 (Confirmed)
ACUR - June 30th, 2009
KG - June 30th, 2009
SPPI – July 2nd, 2009 (Confirmed)
DDSS – July 18th, 2009 (Confirmed)
UTHR – July 30th, 2009
ADLS.OB – July 31th, 2009 (Confirmed)
SVNT - Aug 1st, 2009 (Confirmed) Savient falls ahead of Krystexxa panel review: Associated Press Business News - MSN Money
NRI.TO or NRIFF.PK - Aug 5th, 2009 (Confirmed)
NGSX – Aug 16th, 2009 (Confirmed)
AUXL – Aug 28th, 2009
ISTA - Sept 12th, 2009
ALTH – Sept 24th, 2009
SPPI - Oct, 8th, 2009 (Confirmed)
AMGN – Oct 19th, 2009
MEDX - Oct 21th, 2009
ACOR – Oct 22nd, 2009
GTXI - Oct 30th, 2009
TSPT - OCt 31th, 2009 (Confirmed)
DYAX - Dec 1st, 2009
SOMX - Dec 4th, 2009
MELA - Dec 4th, 2009
SNTS - Dec 4th, 2009
VION.OB – Dec 12th, 2009 (Confirmed)
OSUR - Dec 31, 2009
ILE - Jan 4th, 2010

ICAD - Seeking U.S. Clearance of Computer-Aided Detection Technology
CTIC - Submitted NDA for pixantrone this month. If granted, would lead to a FDA decision date no later than Dec 2009spacepenguin
SNTS - pending
APPA - pending
ARCA - pending
DSCO - pending
BVX - 510(k) submission to the FDA seeking pre-market clearance for a laparoscopic SEER device for solid organ resection, and working toward 510(k) filings for its BOSS orthopedic tissue resection device and Polarian vessel sealing technology.
NSPH - received FDA clearance for its influenza and respiratory syncytial virus (RSV) test which leaves three 510(k) applications still pending at the FDA with estimated decisions during 2H09

Feel free to make corrections or add additional dates.

kab

schwi105 · 06-06-2009, 09:06 PM

Let us get this post rolling.

NRI.TO or NRIFF.PK August 5th 2009

ttnt111 · 06-06-2009, 09:25 PM

neph-6/13
acur-6/30
kg-6/30
tspt-7/30
ista-9/12
somx-12/4
mela-12/4
snts-12/4

fas917 · 06-10-2009, 03:52 PM

medx 10/21
dyax 12/01
icad 12/31
osur 12/31
ile 1/04/10

w00tw00t · 06-10-2009, 04:03 PM

DSCO pending XD

Ingwe · 06-11-2009, 03:51 PM

Note that TSPT received notification today that the FDA will be extending the review period of their NDA. PDUFA decision date was 7/30 but will now be pushed out another 3 months.

The stock took a 0.50 hit today -- a decent pullback if you have confidence in the company/product.

mahmissa · 06-11-2009, 04:19 PM

Thanks for putting this together!

About SVNT, shares are selling off prior to FDA meeting.
Savient falls ahead of Krystexxa panel review: Associated Press Business News - MSN Money

spacepenguin · 06-11-2009, 07:50 PM

What does ICAD have up for approval on Dec 31?

The only thing I'm aware of is their 510(k) application, submitted in May, for VeraLook "virtual" colonoscopy. The FDA usually responds to the application within 90 days.

kabilius · 06-11-2009, 11:09 PM

Yeah mahmissa,
Thanks for the info., I just wish the analyst had told us this two days ago when I bought some SVNT shares....

Well, at least I know why the price is dropping daily...

Spinner · 06-12-2009, 02:20 PM

Originally Posted by kabilius

Yeah mahmissa,
Thanks for the info., I just wish the analyst had told us this two days ago when I bought some SVNT shares....
Well, at least I know why the price is dropping daily...

But you feel pretty good about buying those SVNT shares right now, don't you!

Good call!

Cheers, Spinner

06-06-2009, 09:04 PM	#1
kabilius VIP Trader Join Date: Jun 2009 Location: LA Posts: 131 Favorites: VG, POZN, SUPG Rep Power: 46 Reputation: 653	[Update 06/13] Food / drug approval decision dates Hi all, I found this online yesterday and thought I'd share this with you all. (since there are a lot of biotech buyers here) Calender of expected U.S. food and drug administration approval decisions Following are the contributors: schwi105, ttnt111, fas917, w00tw00t, Ingwe, mahmissa, spacepenguin, Sharpie List is updated on June 15th, 2009 HEB – May 25th, 2009 NEPH.OB - June 13th, 2009 SVNT – June 16th, 2009 (drug to be reviewed by Arthritis Advisory Committee appointed by the FDA) BDSI – June 15th, 2009 (Confirmed) ACUR - June 30th, 2009 KG - June 30th, 2009 SPPI – July 2nd, 2009 (Confirmed) DDSS – July 18th, 2009 (Confirmed) UTHR – July 30th, 2009 ADLS.OB – July 31th, 2009 (Confirmed) SVNT - Aug 1st, 2009 (Confirmed) Savient falls ahead of Krystexxa panel review: Associated Press Business News - MSN Money NRI.TO or NRIFF.PK - Aug 5th, 2009 (Confirmed) NGSX – Aug 16th, 2009 (Confirmed) AUXL – Aug 28th, 2009 ISTA - Sept 12th, 2009 ALTH – Sept 24th, 2009 SPPI - Oct, 8th, 2009 (Confirmed) AMGN – Oct 19th, 2009 MEDX - Oct 21th, 2009 ACOR – Oct 22nd, 2009 GTXI - Oct 30th, 2009 TSPT - OCt 31th, 2009 (Confirmed) DYAX - Dec 1st, 2009 SOMX - Dec 4th, 2009 MELA - Dec 4th, 2009 SNTS - Dec 4th, 2009 VION.OB – Dec 12th, 2009 (Confirmed) OSUR - Dec 31, 2009 ILE - Jan 4th, 2010 ICAD - Seeking U.S. Clearance of Computer-Aided Detection Technology CTIC - Submitted NDA for pixantrone this month. If granted, would lead to a FDA decision date no later than Dec 2009spacepenguin SNTS - pending APPA - pending ARCA - pending DSCO - pending BVX - 510(k) submission to the FDA seeking pre-market clearance for a laparoscopic SEER device for solid organ resection, and working toward 510(k) filings for its BOSS orthopedic tissue resection device and Polarian vessel sealing technology. NSPH - received FDA clearance for its influenza and respiratory syncytial virus (RSV) test which leaves three 510(k) applications still pending at the FDA with estimated decisions during 2H09 Feel free to make corrections or add additional dates. kab __________________ Rule #1 of a stock investor - Say no to greed Last edited by kabilius; 06-16-2009 at 01:29 AM..
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06-06-2009, 09:06 PM	#2
schwi105 UberTrader Join Date: May 2009 Location: Minneapolis Posts: 124 Favorites: PWRM; ADXS; MHTX Rep Power: 70 Reputation: 1291	Let us get this post rolling. NRI.TO or NRIFF.PK August 5th 2009
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06-06-2009, 09:25 PM	#3
ttnt111 Junior Trader Join Date: May 2009 Location: us Posts: 25 Favorites: acus.pk, ctic, dptr Rep Power: 20 Reputation: 118	neph-6/13 acur-6/30 kg-6/30 tspt-7/30 ista-9/12 somx-12/4 mela-12/4 snts-12/4 Last edited by ttnt111; 06-06-2009 at 10:36 PM..
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06-10-2009, 03:52 PM	#4
fas917 Junior Trader Join Date: Jun 2009 Location: NYC Posts: 20 Rep Power: 18 Reputation: 79	medx 10/21 dyax 12/01 icad 12/31 osur 12/31 ile 1/04/10
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06-10-2009, 04:03 PM	#5
w00tw00t Senior Trader Join Date: Jun 2009 Location: Genk Posts: 160 Rep Power: 0 Reputation: 744	DSCO pending XD
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06-11-2009, 03:51 PM	#6
Ingwe VIP Trader Join Date: May 2009 Location: San Francisco Posts: 72 Favorites: LVS, MGM, AAPL, CTIC Rep Power: 41 Reputation: 619	Note that TSPT received notification today that the FDA will be extending the review period of their NDA. PDUFA decision date was 7/30 but will now be pushed out another 3 months. The stock took a 0.50 hit today -- a decent pullback if you have confidence in the company/product.
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06-11-2009, 04:19 PM	#7
mahmissa UberTrader Join Date: May 2009 Location: Washington Posts: 294 Favorites: BAC, HEB, LVS Rep Power: 124 Reputation: 2450	SVNT Thanks for putting this together! About SVNT, shares are selling off prior to FDA meeting. Savient falls ahead of Krystexxa panel review: Associated Press Business News - MSN Money __________________ Mahmissa May you live all the days of your life- Jonathon Swift Last edited by mahmissa; 06-11-2009 at 04:34 PM..
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06-11-2009, 07:50 PM	#8
spacepenguin VIP Trader Join Date: May 2009 Location: Geneseo Posts: 47 Favorites: CTIC, SPNG, INTC Rep Power: 50 Reputation: 853	What does ICAD have up for approval on Dec 31? The only thing I'm aware of is their 510(k) application, submitted in May, for VeraLook "virtual" colonoscopy. The FDA usually responds to the application within 90 days. __________________ Been trading since 2009 March 27
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06-11-2009, 11:09 PM	#9
kabilius VIP Trader Join Date: Jun 2009 Location: LA Posts: 131 Favorites: VG, POZN, SUPG Rep Power: 46 Reputation: 653	Yeah mahmissa, Thanks for the info., I just wish the analyst had told us this two days ago when I bought some SVNT shares.... Well, at least I know why the price is dropping daily... __________________ Rule #1 of a stock investor - Say no to greed Last edited by kabilius; 06-11-2009 at 11:16 PM..
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