Forum > How do you find beforehand if a stock is close to FDA approval?
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Posted June 04, 2009 (08:26PM)
Is there a website that lists all stocks that are close to FDA approval?
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Posted June 04, 2009 (09:22PM)
One can find the PDUFA dates but they can be rescheduled and nobody knows if the application will be approved and any limitations involved
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Posted June 05, 2009 (12:16PM)
If you want to be a real smart ass call FDA up and pretend to be working for the company.
''Inside'' info ;] |
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Posted June 05, 2009 (12:25PM)
http://www.tradingmarkets.com/
Posts info regarding that stuff sometimes... I haven't rummaged around to find one for June, but just for the sake of an example, here's the one I saw for May: http://www.tradingmarkets.com/.site/news/TOP%20STORY/2319254/ |
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Posted June 05, 2009 (01:08PM)
I don't know how many trades you do a month, russian.. but if you do at least 25, you can get the streaming quotes and along with that is the very earliest news that comes out. My only problem is getting in my bids when I see them, but any news of FDA approvals show up there. It sure worked yesterday with XTNT and today it worked with PMTI. |
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Posted June 05, 2009 (11:18PM)
OK so here is the basic list that i have for the year 2009.
Savient Pharmaceuticals Drug/indication: Krystexxa for gout FDA advisory panel date: June 16 FDA decision date: Aug. 1 BioDelivery Sciences Drug/indication: Onsolis for breakthrough cancer pain FDA decision date: June 15 Spectrum Pharmaceuticals Drug/indication: Zevalin for non-Hodgkin's lymphoma FDA decision date: July 2 Labopharm Drug/indication: DDS-04A for depression FDA decision date: July 18 United Therapeutics Drug/indication: Tyvaso for pulmonary arterial hypertension FDA decision date: July 30 Advanced Life Sciences Drug/indication: Restanza for community-acquired pneumonia FDA decision date: July 31 NeurogesX Drug/indication: Qutenza for neuropathic pain FDA decision date: Aug. 16 Allos Therapeutics Drug/indication: Pralatrexate for peripheral T-cell lymphoma FDA decision date: Sept. 24 Amgen Drug/indication: Denosumab for osteoporosis FDA decision date: Oct. 19 Acorda Therapeutics Drug/indication: Fampridine for multiple sclerosis GTx Drug/indication: Acapodene for prostate cancer FDA decision date: Oct. 30 Vion Pharmaceuticals Drug/indication: Onrigin for acute myelogenous leukemia FDA decision date: Dec. 12 |
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Posted June 06, 2009 (01:56AM)
I think SVNT has some event in June. With two weeks to go options are very expensive. Underlying is around 7.50 now and the 7.50 ATM straddle is around $3.50, 50% of the price of the shares. Wow!
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Posted June 06, 2009 (07:09AM)
I might point out here, that the FDA advisory panel decisions are big events also and tend to make stocks bullish. Regarding 'Advanced Life Sciences' (ADLS), on June 2, an FDA advisory panel voted 11-3 to recommend against Restanza's approval. The FDA generally,but not always, listens to the advice of its advisory panel decisions. If you check the charts you will see that the stock did drop significantly that day. Also, to add to the list: AMAG Pharmaceuticals (AMAG) FDA decision date is June 26 but shares of this have already been climbing, and could possibly be too late to get in? Auxilium Pharmaceuticals (AUXL) FDA decision date is August 28 This one has not made a significant move yet, and in fact was down over a half buck at close on Friday June 5, so could be a good possible? Of course, there is still Hemispherx Biopharma (HEB) that everyone has been touting. There is something odd about that stock, and it did drop considerably on Friday and personally, I think I will pass on it now. Rumors being rumors.. :) |
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Posted June 06, 2009 (07:15AM)
I posted this before I got around to amending my statement there when I said could possibly be too late to get in?..Nawwww..but then you never really know if the drug will get the FDA approval, so might think about scaling into this one? :) |
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Posted June 06, 2009 (12:08PM)
From what I have heard the "HEB" approval or regection will be Monday . |
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Posted June 06, 2009 (03:26PM)
Sorry, I missed the part with June 16 date advisory panel for SVNT. It is nice when theory and practice align - options have priced the event with > 300% volatility. FDA does not have to follow the recommendation of its advisory panel but they usually do
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Posted June 07, 2009 (08:22AM)
Adding to aforementioned list of drugs up for FDA approval:
ISTA Pharmaceuticals (ISTA) FDA advisory committee to review Bepreve for the treatment of eye itching June 26 This stock seems to be flying under the radar for some reason that I couldn't put a finger on. Maybe someone else will see something I missed about it, but for having announced an FDA NDA meeting on this new drug, I don't see significant interest in it...yet. Personally, I am not going to let happen what has happened to me the past few trading days and let one slip by.. this puppy is going into my account first thing Monday morning. ;) |
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Posted June 12, 2009 (02:29PM)
SVNT is up > 50% today on rumors that the FDA says the gout drug is working. Congratulations if you had the conviction to go long, my condolences for the shorts
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Posted June 12, 2009 (03:19PM)
No, sadly OF, I did not go with SVNT, and obviously very sorry I didn't. I am hoping to make up for it with BDSI. I liked what I saw in the comparisons of the charts between SVNT and BDSI for the dates this thread ran for, before today, And to back up my believe I will freely admit that I just purchased 500 shares of BDSI for $6.74. I am susceptible to any and all critiques of this trade. :) |
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Posted June 12, 2009 (08:17PM)
i too didnt go in on SVNT. =( i actually like how the chart looks for SSPI.
BDSI and SSPI will be one of my orders for monday. |
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Posted June 12, 2009 (08:32PM)
Wow, and I was thinking about buying some SVNT yesterday, but I thought it had not bottomed out yet. Kicking myself over this one. Oh well, can't win them all.
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Posted June 12, 2009 (08:42PM)
I guess I will critique this one myself. Bought at 6.74... afterhours trading took it to 7.55.. 12% gain.. I can live with it. ;) And like SVNT, it is just now crossing back up over the 200 DAY SMA |
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Posted June 12, 2009 (10:12PM)
I chickened out as well. Did not go long and put some complex position, sold a spread to get the money for extra calls. If the FDA panel recommends the approval on Tuesday, it will be OK
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Posted June 12, 2009 (11:03PM)
As an update to this post, one week later, AMAG down 3%.... AUXL is 14% higher .... HEB is down 15%(this is from Monday-Fri)(but down 38% from Friday-Friday) Personal belief is that it is buy time for AMAG and AUXL, but stay away from HEB. Heck, if that friggin Cramer can say anything he wants, so can I. ;) To be continued... ;) |
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Posted June 12, 2009 (11:54PM)
Bret, your thoughts on ADLS??
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