B*****e 发帖数: 2413 | 1 It was recommended by advisory committee @13:7, but it was later rejected
for heart risk by FDA and was asked for the data of heart risk.OREX will
resubmit the application.
http://thestockmarketwatch.com/stock-market-news/hot-stocks-to-
plunges-after-us-fda-rejected-its-diet-drug/5099
Cash $25 Million + 67 M short term investments. Market cap: $146M
Recently several funds bought orex, especially FMR just bought 12.31% of
orex. | B*****e 发帖数: 2413 | 2 Nobody is interested? Anybody is familiar with OREX?
rejected
watch/orex-
【在 B*****e 的大作中提到】 : It was recommended by advisory committee @13:7, but it was later rejected : for heart risk by FDA and was asked for the data of heart risk.OREX will : resubmit the application. : http://thestockmarketwatch.com/stock-market-news/hot-stocks-to- : plunges-after-us-fda-rejected-its-diet-drug/5099 : Cash $25 Million + 67 M short term investments. Market cap: $146M : Recently several funds bought orex, especially FMR just bought 12.31% of : orex.
| g*******x 发帖数: 2158 | 3 Interested, but not familiar with its products. | b*****h 发帖数: 783 | 4 FDA has clearly stated in CRL "before your application can be approved, you
must conduct a randomized,
double-blind, placebo-controlled trial of sufficient size and duration to
demonstrate that the risk of major
adverse cardiovascular events in overweight and obese subjects treated with
naltrexone/bupropion does not
adversely affect the drug's benefit-risk profile."
I dont think they can resubmit without clinical trial in the near future.
【在 B*****e 的大作中提到】 : It was recommended by advisory committee @13:7, but it was later rejected : for heart risk by FDA and was asked for the data of heart risk.OREX will : resubmit the application. : http://thestockmarketwatch.com/stock-market-news/hot-stocks-to- : plunges-after-us-fda-rejected-its-diet-drug/5099 : Cash $25 Million + 67 M short term investments. Market cap: $146M : Recently several funds bought orex, especially FMR just bought 12.31% of : orex.
| B*****e 发帖数: 2413 | 5 All right! I do think that there is no more space for price down. I just
hold it for a while.
you
to
with
future.
【在 b*****h 的大作中提到】 : FDA has clearly stated in CRL "before your application can be approved, you : must conduct a randomized, : double-blind, placebo-controlled trial of sufficient size and duration to : demonstrate that the risk of major : adverse cardiovascular events in overweight and obese subjects treated with : naltrexone/bupropion does not : adversely affect the drug's benefit-risk profile." : I dont think they can resubmit without clinical trial in the near future.
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