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I was wondering the same thing LOL
Understanding "Bumps in the Road"
Bumps in the Road
If the FDA decides that the benefits of a drug outweigh the risks, the drug will receive approval and can be marketed in the United States. But if there are problems with an NDA or if more information is necessary to make that determination, the FDA may decide that a drug is "approvable" or "not approvable."
A designation of approvable means that the drug can probably be approved, provided that some issues are resolved first. This might involve the sponsor and the FDA coming to a final agreement on what should go on the drug's labeling, for example. It could also involve more difficult issues, such as the adequacy of information on how people respond to various dosages of the drug.
A designation of "not approvable" describes deficiencies significant enough that it is not clear that approval can be obtained in the future, at least not without substantial additional data.
Common problems include unexpected safety issues that crop up or failure to demonstrate a drug's effectiveness. A sponsor may need to conduct additional studies--perhaps studies of more people, different types of people, or for a longer period of time.
Manufacturing issues are also among the reasons that approval may be delayed or denied. Drugs must be manufactured in accordance with standards called good manufacturing practices, and the FDA inspects manufacturing facilities before a drug can be approved. If a facility isn't ready for inspection, approval can be delayed. Any manufacturing deficiencies found would need to be corrected before approval.
"Sometimes a company may make a certain amount of a drug for clinical trials. Then when they go to scale up, they may lose a supplier or end up with quality control issues that result in a product of different chemistry," says the FDA's Kweder. "Sponsors have to show us that the product that's going to be marketed is the same product that they tested."
John Jenkins, M.D., director of CDER's Office of New Drugs, says, "It's often a combination of problems that prevent approval." Close communication with the FDA early on in a drug's development reduces the chance that an application will have to go through more than one cycle of review, he says. "But it's no guarantee."
The FDA outlines the justification for its decision in an action letter to the drug sponsor. When the action is either approvable or not approvable, CDER gives the sponsor a chance to meet with agency officials to discuss the deficiencies. At that point, the sponsor can choose to ask for a hearing, or correct any deficiencies and submit new information, or they can withdraw the application.
http://www.fda.gov/Fdac/features/2002/402_drug.html
I found this interesting...
"While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies (FDA (USA), TGA (Australia), EMEA (European Union), etc.)."
How many Phase III trials has Genasense had thus far? It sounds like commonplace for an NDA to be given the "Need more clinical study data" response from the FDA. I don't see what the panic is all about?
This drug will be approved. They're too close to just throw it all away.
"Why do you think the stock went from .15 to .01 and lower in 1 day? Self -explanatory."
By looking at the chart, it looks like huge amounts of selling going on right around the 8th, and nothing to do with 6B shares being added. I guess I'm failing to see the self explanatory part. Care to point it out to me? Thanks.
Can someone here please explain this for me?
Item 8.01. Other Events
On October 6, 2008, Genta Incorporated, a Delaware corporation (the "Company"), held its 2008 Annual Meeting of Stockholders (the "Annual Meeting"). The total number of outstanding shares of common stock entitled to vote at the Annual Meeting was 36,760,558. The Company's stockholders were asked to consider and vote upon the following two proposals:
(i) to elect five Directors to the Company's Board of Directors to serve a one-year term expiring at the next Annual Meeting of Stockholders and until such Director's successor shall have been elected and qualified; and
(ii) to approve an amendment to the Company's Restated Certificate of Incorporation, as amended, to increase the total number of authorized shares of capital stock available for issuance from 255,000,000, consisting of 250,000,000 shares of common stock and 5,000,000 shares of preferred stock, to 6,005,000,000, consisting of 6,000,000,000 shares of common stock and 5,000,000 shares of preferred stock. On October 6, 2008, the inspector of election certified the results of the vote as follows:
Proposal 1
Name of Board Nominee For Withheld
Martin J. Driscoll 23,814,486 1,631,824
Christopher P. Parios 23,819,431 1,626,879
Daniel D. Von Hoff 23,800,102 1,646,208
Raymond P. Warrell, Jr. 23,768,345 1,677,965
Douglas G. Watson 23,826,234 1,620,076
For Against Abstain Proposal 2 20,900,129 4,341,140 205,041
For Proposal 1, each Nominee received the affirmative vote of a plurality of the shares of Common Stock cast by the stockholders present in person or represented by proxy at the Annual Meeting. For Proposal 2, the Company received the affirmative vote of a majority of the outstanding shares of the Company's Common Stock. Therefore, each proposal was approved by the requisite number of votes at the Annual Meeting.
_____________________________________________________
How many outstanding shares are now outstanding? Are we saying 6b?
Look at all the buying going on...
Loving this action today!
I was able to get another 25,000 @ .0045!
Getting a nice little run here...
Leigh and Poster...
I wasn't speaking to you, specifically. It was more of a general request for everyone.
I agree, oregon. In fact, this is a play for me that I shouldn't even take another look at until mid January. This thing is going to bounce around between 5 and 6 until that time. It's a hold for me, no matter what the pps is until that time.
Yessir, I do. I own 30,000.
TN, how many...
more times are you going to post the same news snippets? LOL
I would agree.
His post didn't garnish so much as one reply on Hotstockmarket.com before it was shrugged off the front page.
My recommendation would be to do the same here and drop it.
We got some news!
Sure, it was Hotstockmarket.com
Here is the post, it's the last one.
http://www.hotstockmarket.com/forums/showthread.php?t=65556&page=3
His first post on another board was about this same topic. Troll.
Of all the stocks that I own, I feel like GNTA has the greatest upside. This thing could move like a rocketride with the right news.
Is this going to do anything today?
Brezlin, best of luck tonight from an East Carolina fan and graduate!
You're reaching for straws here, in my opinion. Look, I want this company to skyrocket just as much as anyone. Like I said, I'm in with 250k.
But I just want you guys to be prepared if nothing is announced this week. It doesn't mean the company doesn't have great long term prospects if nothing comes out of the meeting.
You have to applaud the leadership team from ASFX for holding a shareholders meeting, though. At the very least, it shows transparency.
I'm just saying that they announced that they were going to have this meeting a while back. It's not an impromptu meeting. Further, I stated that a lot of pinks don't have these meetings, so that by ASFX having one, it was a good sign. A sign of strength and direction.
That being said, this meeting has been on the ASFX radar for some time. I wouldn't expect any big news.
They said over a month ago that they would have an annual shareholders meeting. I think this is just a routine meeting, but it's good thing they hold meetings like this...a lot of company's don't.
Has everyone come to an agreement on the stock price until after the shareholder's meeting? No trades in 30 minutes.
Sorry, I didn't mean to be a wet blanket. Just saying, it's important to not get ahead of yourself. You don't want to be let down more than you need to be if something doesn't work out.
Don't forget guys and gals, I'm a buyer too...and a holder.
Look....
I own 250,000 shares of this company, so I want to see it do well. But there is some serious pumping going on here by a few sunshine folks.
I love ya guys, but let's wait until something actually happens before we s@#^ our pants. I haven't seen anything concrete to get me too excited. I am invested and hopeful, though.
Enough with the sunshine, it's getting to be a turnoff.
What makes you think it looks real good?
I know, I couldn't believe it. I had just gotten off the plane in Newark and checked in. Pretty sweet!
Let's hope for a nice run today!
I was able to add 20k more yesterday at the .0049 dip. When I refreshed my position on my blackberry, I was like "holy @#%%!"...I was able to get 20k of the 50k I wanted. It was a nice gift because 10 minutes later, we were back to .006.
Looking for a nice run today. Currently holding 195k avg .0053
I own 150k. If it dips back below .005, I'm going to pick up another 150k.
No big deal here!
This baby took a lick (although I'm not sure why with that news release!) and is gonna keep on ticking.
Tic, Tic, Tic!!
I was just hoping it would drop a little lower so I could load up on a few more.
Whoohooo!!
Thanks!
I'm terrible with math...
Ha, so I need some help. I'm also a self-admitted NOOB when it comes to trading. I'm glad I can use you guys as a resource. :)
If I bought 90,000 @ .0045
Then
I bought 60,000 @ .0055
What is my average? Can someone show me the formula?
Thanks!
Man, I want to see this thing run.
Just added another 60k at the ask...waiting to get filled.
I've got 100k in at the ask...
Joanne, you're just a ball full of sunshine :)
Let's go baby.
No whammies no whammies!
Hey guys! Mind if I join the party? ;)
Got in this morning 220,000 @0.0031 :)
How are we looking for tomorrow? Hopefully we can close strong and raise a few eyebrows. I feel like we just need a little momentum...sustained momentum.