Small Cap Biotech Important FDA Action Dates for September

[glsharsha]

Here are the FDA action dates for September, enjoy and now go play!

Sept. 1
-FDA advisory Committee meets to review Vion Pharmaceuticals' (ticker: VION) Onrigin, drug for treatment of acute myeloid leukemia.

Sept. 2
-FDA advisory Committee meets to review Allos Therapeutics' (ticker: ALTH) pralatrexate, drug for treatment of lymphoma.

-FDA approval action date for Endo Pharmaceuticals' (ticker: ENDP) Nebido, a long-acting testosterone replacement therapy.

Sept. 7
-FDA approval action date for Spectrum Pharmaceuticals' (ticker: SPPI) Zevalin, a drug for non-Hodgkin's lymphoma.

Sept. 11
-FDA approval action date for Salix Pharmaceuticals’ (ticker: SLXP) Metozolv (Metoclopramide), a drug for treatment of gastroesophageal reflux who fail to respond to conventional therapy

Sept. 12
-FDA approval action date for ISTA Pharmaceuticals’ (ticker: ISTA) Bepreve, a drug for ocular itching associated with allergic conjunctivitis.

Sept. 16
-FDA Advisory Committee meets to review Auxilium Pharmaceutical's (ticker:AUXL) Xiaflex for advanced Dupuytren's disease.

-FDA approval action date for Theravance's (ticker: THRX) antibiotic Telavancin.

Sept. 24
-FDA approval action date for Eurand Pharmaceuticals' (ticker: EURX) Zenpep, a drug for pancreatic insufficiency.

-FDA approval action date for Allos Therapeutics' (ticker: ALTH) Pralatrexate, a drug for peripheral T-cell lymphoma.


Hope you guys will pocket some money with these stocks..

Happy Trading,

Be RICH....

[vupi]

Is the FDA agenda for the last quarter 2009 already available.

[dlvr073]

Great informative thread. Could someone explain the difference between a review and an approval action date. Does one generally move a stock more than the other.

[basuanand]

Great informative thread. Could someone explain the difference between a review and an approval action date. Does one generally move a stock more than the other.

I hope by review you meant "FDA advisory Committee meets to review..."

FDA advisory committee usually meets to decide whether the drug should be approved or not. This panel votes in favour or against of a drug approval based on its safety, efficacy and need for that drug. Usually the FDA (on approval action date) follows the recomendation of the panel, but its not mandatory for the FDA to follow the recomendation.

Also, an approval by the FDA is definitely a big news than the FDA panel vote. But FDA's action date (PDUFA) comes after panel's recommnedation so it is somewhat a stale and expected event. However, FDA now a days is acting strange and you can't be sure of anything now.

I hope it makes sense!

[basuanand]

Excellent information on FDA Action Dates for September.

[ilterminatore]

4 september: FDA will announce final decision about standard or priority review for Pixantrone (CTIC)

[bsirirat]

Do You have Oct. 2009 FDA Calendar? I am investing at least one month before the FDA date.

[lyme3m]

Do You have Oct. 2009 FDA Calendar? I am investing at least one month before the FDA date.

Before what FDA date?

[dlvr073]

4 september: FDA will announce final decision about standard or priority review for Pixantrone (CTIC)

I hope ths wlll finally get this stock to move. Since I've owned this for about a month now it has been in such a tight range.

[FavStocks]

Do You have Oct. 2009 FDA Calendar? I am investing at least one month before the FDA date.

Why not take a look at the Calendar here? Just click the "Calendar" link on the top menu of the forum. Has tons of dates!