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Saturday, June 23, 2012

Upcoming Fda Approval ARNA, VVUS, HZNP, SLXP, PGNX

Below are the  list of companies waiting for FDA approval. Here is a guideline you should keep in mind while buying /shorting this stocks.
  • If a stocks get FDA approval, it jumps 30-40% easily. 
  • If the market cap is below 1B and FDA denies or give complete response letter then the stocks falls down by 30-40%. For market cap above 5 -10B, there is movement of up or down by 2%.
  • Buying activity in stock starts 3-4 month ahead of FDA decision. Selling activity starts after 3 days of approval.
  • If FDA panel decision doesn't back up drug,  it will  fall. After FDA panel decision, official approval from FDA comes within 1 month.
  • If FDA panel back any stock, it will keep rising till it gets final decision. On final decision date, if stock get approval, stock rises in the morning and then it falls.
  • On receiving complete response, stocks falls and keep falling for atleast 15 -20 days. Buying activity starts after 15 days on anticipation that company will resubmit for FDA approval. 
09/14/2012 GILD FDA decision on Truvada in new indication as HIV preventive therapy
09/10/2012 NEOP, NAVB FDA decision on Lymphoseek for proposed use in intraoperative lymphatic mapping

09/05/2012   SLXP      FDA decision on Crofelemer for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy
08/27/2012 GILD     FDA decision on Quad for treatment of HIV
08/12/2012 TLON.OB     FDA decision on Marqibo in the proposed treatment of adult Philadelphia chromosome-negative acute lymphoblastic leukemia
08/04/2012 REGN FDA decision on Zaltrap for proposed use in metastatic colorectal cancer
07/27/2012   SLXP FDA decision on RELISTOR subcutaneous injection in addnl indication of treating opioid-induced constipation (OIC) in patients with non-cancer pain
07/26/2012 HZNP FDA decision on Rayos for rheumatoid arthritis
07/26/2012 AMRN FDA decision on AMR101 as treatment for very high triglycerides (greater than or equal to 500mg/dL)
07/17/2012 VVUS FDA decision on Qnexa as proposed treatment for obesity
06/28/2012 BMY FDA decision on ELIQUIS for prevention of stroke and systemic embolism in patients with atrial fibrillation
06/27/2012 ARNA FDA decision on Lorcaserin for proposed treatment of obesity
06/21/2012 RGEN SecreFlo (NDA) FDA issues complete response letter for SecreFlo (RG1068)
06/20/2012   SNY        FDA Panel voted 14-1 against approval of Semuloparin
06/20/2012 ONXX FDA panel backs Kyprolis for treatment of multiple myeloma
06/15/2012   GILD FDA decision on truvada postponed by three months to Sep.14
06/10/2012 NEOP, NAVB FDA decision date postponed to September 10, 2012
06/05/2012 SLXP FDA extends decision date by 3 months to September 5 on Crofelemer for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy
06/05/2012 ARIA FDA issues complete response letter for Ridaforolimus. Says additional trial(s) would need to be conducted to further assess safety and efficacy.
05/31/2012 RGEN FDA panel to review SecreFlo for detection of pancreatic duct abnormalities
05/24/2012 PFE           FDA panel voted 13-4 recommending approval of Tafamidis meglumine for transthyretin familial amyloid polyneuropathyin
05/13/2012 TLON.OB  FDA decision on Marqibo in the proposed treatment of adult Philadelphia chromosome-negative acute lymphoblastic leukemia FDA postpones decision on Marqibo by 3 months to August 12
05/11/2012 GILD FDA panel voted 13-1 recommending approval of Quad for treatment of HIV
05/10/2012 GILD     FDA panel voted 19-3 recommending approval of Truvada in new indication as HIV preventive therapy
05/09/2012   PFE       FDA panel backs Tofacitinib for treatment of adult patients with moderately to severely active rheumatoid arthritis
05/08/2012 REGN FDA panel voted 11-0 against approval of Arcalyst
05/04/2012 ALXA FDA issues complete response letter for Adasuve
04/27/2012 PGNX FDA moves decision date by 3 months to July 27
04/27/2012 SLXP FDA decision on RELISTOR on July 27
04/26/2012 AMGN  FDA issues Complete Response Letter for addnl. indication of XGEVA
04/25/2012 FURX FDA issues complete response letter for Alogliptin, and fixed-dose combination therapy Alogliptin and Pioglitazone.
04/24/2012      CTIC (NDA resubmission) to be resubmitted in 2012
04/17/2012 VVUS     FDA postpones decision date by three months to July 17 for Qnexa (NDA resubmission)
04/16/2012 NRI.TO      Pliaglis (sNDA) FDA issued complete response letter for Pliaglis
03/28/2012 CHTP       FDA issues complete response letter for Northera
03/28/2012 BMY FDA extends decision date to June 28 for ELIQUIS (NDA)
03/26/2012 MAPP      FDA issued complete response letter for Levadex

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