View Full Version : DORB in fda meeting
chinaman711
05-09-2007, 02:43 PM
Starting to come back a little
amgdriver
05-09-2007, 04:40 PM
So when will results be released? I bought in the high $.30's and I can't decide whether to sell and just be thankful to get my money back, or hold and hope for the best...
Pytheas
05-09-2007, 05:40 PM
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.
Thierry Martin
05-09-2007, 06:29 PM
1146
booseteaz84
05-10-2007, 01:29 PM
not good
Pytheas
05-10-2007, 03:32 PM
not good
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!
amgdriver
05-10-2007, 04:34 PM
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.
Pytheas
05-10-2007, 11:45 PM
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.
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.
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.
Thierry Martin
05-11-2007, 01:37 AM
1163
chacho
05-14-2007, 05:01 PM
I think it's due for a bounce here. Nice support around .21 with volume drying up. Looking for shorters to cover and buyers to jump back in on this one.
Pytheas
05-15-2007, 08:20 AM
I think it's due for a bounce here. Nice support around .21 with volume drying up. Looking for shorters to cover and buyers to jump back in on this one.
Agreed chacho.
I don't see it going crazy. The FDA shot it down with a 7-2 vote against it.
"DOR BioPharma Inc. (OTCBB: DORB) experienced a rise in share value Friday following 5,904,443 shares traded. On May 9th it was announced that the Oncologic Drugs Advisory Committee appointed by the FDA has voted that the data supporting orBec(R) did not show substantial evidence of efficacy by a margin of 7 to 2 for the treatment of gastrointestinal graft-versus-host disease. Although this news is negative in respect to DOR Biopharma it has spurred a review by our team at PinnacleDigest as we have decided to evaluate this company in respect to their current position in the market. "
I don't think it will be easy to reverse a 7-2 vote with the FDA.
To read this article in its entirety, visit us at www.pinnacledigest.com.
It certainly isn't a long, maybe a short trade, but who's going to buy it with this negative news. They meet again July 7th.
This for me is the major reason that I don't take much stock in T.A. Its a tool but using charts, bollengers etc etc and not current news, current events etc etc the T.A can really hurt you.
Don't get me wrong, I feel T.A. is good when all other things are in good shape, but if the FDA votes down a drug and that is their main staple I don't think any chart anylysis is valid.
Just my thoughts however, for those entering this I hope you make a bundle........ I honestly do, and then I'll reconsider my thoughts "-)
Thierry Martin
05-16-2007, 12:27 PM
1209
What is the yellow on the chart indicating Theiry?
Skifreak
05-16-2007, 12:43 PM
Well the briefing that came out before the review was a bummer this thing is to big imo to just consider it another pump and dump. Yeah the review was a no vote. I like this artical on a drug that was overturned by fda because of survival.
http://findarticles.com/p/articles/mi_m0ISW/is_280/ai_n16850472
Also think this is a pretty good read about overall survival
http://www.fda.gov/cber/gdlns/clintrialend.pdf
So imo there is still a good chance of some good things to come rather it be buyouts, europe approval, and or fda approval
Happy Trading,
Skifreak
chacho
05-17-2007, 10:00 AM
Just read on another board there is a rumor that DORB is reconsidering the buy-out. Take it for what it's worth, I'm skeptic on it. I still think this is due for a bounce, and IF they put this kind of news out, I think it should easily get to the .30's.
JV1298
05-17-2007, 02:01 PM
Can anyone explain why DORB is climbing all of a sudden? I'm not complaining, but I don't see the reason and Im trying to learn this stuff!
Pytheas
05-17-2007, 02:39 PM
Okay, first of all the FDA didnt vote against anything. The "board" appointed by the FDA voted against it. The FDA is not bound by ODAC's decision. Also, Orbec would be the only drug on the market to treat GI GVHD...another plus.
Dumping the stock now would be crazy. And ski, this wont be another pump and dump. By years end I expect to triple my money...but others that got in prior to the drop should buy more to lower their cost average. - thats what i did.
Thierry Martin
05-17-2007, 03:13 PM
What is the yellow on the chart indicating Theiry?
Yellow is to indicate that day on the chart is not over.
Thierry Martin
05-17-2007, 03:16 PM
This thing is climbing back from the dead.
1220
chacho
05-17-2007, 03:44 PM
Weee back in the green, got in a couple days ago at .22. Hopefully this is our reversal and buyers start jumping back in :)
Skifreak
05-17-2007, 05:34 PM
Okay, first of all the FDA didnt vote against anything. The "board" appointed by the FDA voted against it. The FDA is not bound by ODAC's decision. Also, Orbec would be the only drug on the market to treat GI GVHD...another plus.
Dumping the stock now would be crazy. And ski, this wont be another pump and dump. By years end I expect to triple my money...but others that got in prior to the drop should buy more to lower their cost average. - thats what i did.
Who said the fda voted against it? I didnt. "Yeah the review was a no vote." meaning Advisory Panel ReviewWho said it was a pump and dump i didnt. "this thing is to big imo to just consider it another pump and dump" If you are refering to my post please go back and reread it. If not disregard this.
Pytheas
05-18-2007, 07:42 AM
My bad skifreak, I guess i read that too fast.
chacho
05-18-2007, 08:45 AM
gapped up. .255x.26 now :)
Skifreak
05-18-2007, 09:13 AM
My bad skifreak, I guess i read that too fast.
no problem.
It looks like its coming out of an oversold period. IMO this stock is still to cheap it needs to trade in the 30s at least
chinaman711
05-18-2007, 09:51 AM
Back to .30 looking good
Skifreak
05-18-2007, 09:53 AM
yeah you gotta love to see them 100k blocks going through
chacho
05-18-2007, 10:11 AM
ahh i got out way too early. oh well, profit is profit :) :)
BigDawg291
05-29-2007, 06:42 PM
DORB pulled out of a conference that they were scheduled to present in this week and according to two different message boards they left from Italy headed back to their headquarters yesterday. Could be a possible buyout they are looking at b/c they had been offered by CTIC for 1.15 a share before. Could be another offer they have on the table.
JV1298
05-29-2007, 11:39 PM
On May 28, 2007, Steven H. Kanzer resigned as a member of the Company's board of directors (the "Board"). Mr. Kanzer was Vice-Chairman of the Board and a member of the audit, compensation and nominating committees of the Board.
Could be to do with that?
BigDawg291
05-31-2007, 02:15 PM
Today is the day that we should find out what Sigma-Tau's decision is, in regards to the "non-binding" agreement made in January 2007.
The original conclusion was suppose to be April 30th, 2007, but was amended accordingly and announced on May 3rd, 2007, with May 31st, 2007 being the conclusion date.
If amended again, it's very clear that Sigma-Tau wants orBec, and is playing hardball and is trying to work the FDA time table response to their advantage.
DOR management should not extend! If push comes to shove and they can't work the deal out, management should write them a check for the $2 million.
Taking the back up offer from "RBC", has probably already put into motion for them.
amgdriver
06-05-2007, 01:22 PM
So what do these buyout rumors mean? Are things looking up? down? Or are things looking as stagnant as the stock price itself?
Pytheas
06-05-2007, 03:42 PM
So what do these buyout rumors mean? Are things looking up? down? Or are things looking as stagnant as the stock price itself?
buy out rumors are good news weather it happens or not. we wont hear anything until the report comes out at the end of the month IMO. Its been trading low volume, probably waiting for the news like the rest of us.
Skifreak
06-20-2007, 10:23 AM
look like its trying to breakout
Pytheas
06-20-2007, 05:24 PM
look like its trying to breakout
Yep, it sure does. I sold some at .37 and took a nice 30% profit.
Albert0373
08-29-2007, 01:22 PM
Looking to have a nice move again, I bought at .30 and .32; keep a watch on this one.
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