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View Full Version : DORB in fda meeting



Alealokato
07-03-2017,
Although the meeting vote wasnt positive, I think there is still an upside to this stock.

MIAMI, FL, May 09, 2007 (MARKET WIRE via COMTEX) -- DOR BioPharma, Inc. ("DOR," or "The Company") announced today that the Oncologic Drugs Advisory Committee ("ODAC") appointed by the U.S. Food and Drug Administration ("FDA") voted that the data supporting orBec(R) (oral beclomethasone dipropionate) did not show substantial evidence of efficacy by a margin of 7 to 2 for the treatment of gastrointestinal graft-versus-host disease ("GI GVHD"). The FDA is not bound by ODAC's recommendations, but it will take the panel's advice into consideration when reviewing the New Drug Application ("NDA") for orBec(R). The FDA has said it will respond to DOR's NDA by July 21, 2007, under Prescription Drug User Fee Act ("PDUFA") guidelines.

AlbertinaD
07-04-2017,
are you kidding? I bought more at .25, lower my cost average.

DORB also filed a Marketing Authorization Application ("MAA") with the European Central Authority, European Medicines Evaluation Agency ("EMEA") for orBec, which has also been validated for review.

I'm in this one for a nice ride up in the future!

Albertsmact
07-05-2017,
Pytheas, what kind of an upside do you see in this stock? Today's ~45% drop hurt (but obviously I would never jump into a stock like this without knowing the risks ahead of time). Do you see it climbing back to where it was last week anytime soon? Do you think that this bad news will cripple the firm and put it in a downward spiral? Obviously it is all speculation, and I don't foresee it shooting through the roof anytime soon, but if it should ever climb back up to its original price, my position at $.40 wouldn't be so bad.

AlbaMcGarr
07-05-2017,
There is much more with DORB's OrBec. Althought primary endpoints were not met, the key statistics have to do with survival, and patient rebound. OrBec has been in the works for over 15 yrs, and the drug isn't complete garbage. DORB is at a great price for a buyout right now. The NDR has not been rejected... bad news is wrapped around advisory panel's decision. FDA has voted against their panel multiple times though. Also, from what I found, they have enough money to go thru the end of the year.

admin
07-07-2017,
DORB also has the euro play going for it, if it passes there you can easily double your money in a couple of days. Timeline wise, we may have to hold on to it for a little bit, 3-6 months, the longest I hope. As for the price, I dont see it going any lower. (however, i did buy more at $.25 because I didnt anticipate a drop this low to begin with)

Final thoughts: I say hold on to it! I feel the worse case scenerio is you break even.