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We'll see what happens.
Generally, bad news like an FDA non-approval for a drug application, has a negative impact on a stock. You're not willing to face reality if you think this isn't going to fall.
Q1 earnings...
...are going to be a real eye opener for a lot of people.
You're really reaching, nutriman.
...you're crazy if you think this stock isn't going to nose dive next week. This pps has been driven up since mid to late January on hopes of CLL approval. It's going to fall.
Nope, I'm not that lucky ;)
Sometimes someone makes such a good decision...
...people want to say "he knew something". You're giving me way too much credit. I played this stock the way ANYONE who bought in the low pps's who didn't believe CLL would be approved should've played it.
I'm sorry for your loss, smitter, but to blame your loss on any one individual instead of yourself is just silly. If you made money here on the run up due to CLL speculation approval and you didn't think it would get approved, you would've taken your money out as well.
You should've done more DD. I'm glad I did mine and now I'll be able to get back in at a MUCH lower price in preparation for why I was in this stock to begin with. If you or anyone else thinks this stock isn't going to fall on Monday, you're fooling yourself. All it's going to take is one person hitting the eject button and everyone else will follow suit.
That's my prediction and I'm looking forward to next week.
I've admitted this over 100 times.
It is important to realize...
...that the FDA asked for a confirmatory phase III study for the approval of Genasense in CLL. They did not get one.
The FDA and the EMEA asked for an additional clinical study in order to confirm efficacy and safety of a prior phase III study in the treatment of melanoma. The are getting one.
The Agenda Trial is a confirmatory study of a specific subset in a prior phase III study. This confirmatory study looks at individuals in the prior phase III study with low to normal LDH levels, who showed MAXIMUM BENEFIT and supported the approval of Genasense + chemotherapy in the treatment of melanoma, world-wide. They are confirming using this subset ONLY. They only need to reproduce the results of the prior phase III study in this group. That's what they're trying to accomplish. They're nearly fully enrolled (if not completely enrolled already).
Bingo...
...I'll be back in at a lower pps when people sell off on this news. I can invest my profits from getting out at the right time. I'll get back in for the Agenda Trial. Those of you who are mad at me for making good trades are just upset that they didn't also stop to look at the situation from end to end.
That's before I came to the...
...realization that everyone I came across was in this stock for CLL approval. You should've been smart enough to realize that wasn't going to happen.
We'll see, nutriman. Best of luck...
...I doubt it. It's going to sell off, but I hope for your interest that it doesn't. You're one of the good guys, we just see it differently.
I think they probably could...
...pull it off, but aren't prepared or simply can't spend the money on another mult-million dollar trial.
Some of you need to quit reading only what you want to read.
The CEO has clearly stated several times that the Agenda Trial is the #1 priority for this company. They're not going to pump money into a new clinical trial while the Agenda Trial is ongoing and needs all of their resources to be completed.
Genta likely saw this as far back as 2007 and has never been financially prepared to start up a new confirmatory study for the treatment of CLL. Those dollars have been set aside for their #1 priority, the Agenda Trial.
So they are just exhausting every possibility through appeals, new data, etc., anything they can to gain approval from the FDA without having to kick in millions of dollars for a new trial.
The Agenda Trial can't be made to suffer, financially, when its' right at the finish line.
It's not good news at all...
...it's terrible news. They got denied and anyone who tries to spin this is out of their mind. Period. This is what I was afraid of and it all but puts the final nail in the coffin for Genasense as it relates to CLL. That's a fact (unless someone wants to partner with them specifically for this application). They are not going to scrape the bottom of the barrel for funds to start a new clinical trial (which costs millions of dollars) when the Agenda Trial needs all their focus and money. The CEO said it's their #1 priority.
The Agenda Clinical Trial is a different story and will receive the last dime Genta has in order to be completed end to end.
Banking on CLL is missing the boat.
Think Agenda.
The "overwhelming"
...statement was in reference to Genasense performance in the treatment of melanoma, the Agenda Trial....not CLL.
It's either hold or average down...
...the Genta story isn't over by long shot.
Agenda Trial baby
This stock is very fragile right now.
It's all about momentum and fear...
...the first person to kick over the dominos can shake out more weak hands for sure.
That was a GNTA powermove.
The 1st quarter report is going to be good.
I'm not a paid pumper.
I thought this stock was undervalued at 1 penny...way undervalued with everything on the line for 2009.
As soon as all those people who had their money on CLL approval shake out, I'll get back in the game. I think the price started to run up in the mid 5's. It might be a decent guess that even with CLL non-approval on this appeal, all the CLL hopers will be out and we can call a bottom.
I didn't realize I had so much power...
...if this gets too much lower, I'm getting back in the game.
Did you buy at the ask?
I actually think this is about to move up
Hot damn!
Let's go, we can use a solid day here...looking good pre-market!
Ding ding ding...we have a winner
I'll tell you why...
...because I'm an affiliate of someone who works in GCIB for one of the largest banks in the world. Being an affiliate, I HAVE TO, by law, hold stocks for 30 days. I can't buy one day, then sell the next...or the person I'm affiliated with will be fired. So if a stock I'm in starts tanking, I have 2 choices...suck it up and watch it drop, or average it down. None of this is really your business, to be honest, but I'm telling you to get you to realize that I don't have any sort of hidden agenda here. I'm not a pumper. I'm not associated with the company. Nothing. I'm just a guy like you are trying to make some money.
Smitter, I'm sorry you feel that way. I wish you the best and I hope that you do well here, I mean that. I hope everyone does well here. I have more than one stock and they are all in the gutter. Go take a look at ASFX for example. I invested thousands of dollars there at .0055. It was trading today at .0007...I have a few of those. Take BAC for example, I'm holding a few thousand shares at 7.97. Needless to say, I'm in the hole pretty bad. I PERSONALLY can not afford to take another hit right now...I just can't do it. It's up to you to determine whether or not you can. Maybe you can afford to take a 5k hit, but with ALL of the stocks in my portfolio performing so poorly, I have to minimize my own PERSONAL risk.
I really hope you, and everyone else, can see it from my perspective. My getting out today has nothing to do with whether or not this stock will be approved or not approved. It has to do with me realizing that a non-approval IS a possibility and with that possibility would come a loss I can't take.
I wish everyone the best here and I'll continue to post here if you'll let me. I still believe in Genta and I think it's a great play for those who can afford to lose if a non-approval is handed down. I can't afford it. I'm minimizing my exposure. Thats it.
That's ok, smitter!
I owned much, much more than 90k shares total. I'm not a paid pumper whatsoever. People are free to speculate as they please.
I'm comfortable with my choice to get out for the moment.
You could very well be right, nutriman. However, I think you would agree that the pps certainly is not going to go UP with non-approval from the FDA. At the very least there are a FEW investors who have actually bought in for the CLL approval. They will likely bow out with a negative response from the FDA.
Either way, I'm buying on FDA PR day. I'm chasing or I'm buying lower.
I'm prepared to live with that.
Same here, nutriman.
If this stock gets back down to the .005-.006 range, I will double my old position.
Agreed.
Maybe so!
I would've posted it in both places....
...it wasn't like I was choosing a group. I was at work and wasn't able to post an update here, I didn't have enough time. I just walked in the door, grabbed the laptop and explained my position.
I hope like hell approval comes. I'm definitely assuming some risk at this point taking my chips off the table. It's a "safer" play for me at this point, considering the rest of my stocks are literally in the sh@#ter.
I'm here to take my lashes...
In all seriousness, the people who are worried about the stock have missed what I was saying since the beginning. Many of them were pulling for CLL approval, while i was in it for another reason...the Agenda Trial and a Tesetaxel partnership.
Over the past month, this stock has run up on speculation of approval in the treatment in CLL. I have to take some profits here as they have become unexpected gains from something that I never had my money on to begin with. That's that.
I hope this thing does get approved for the treatment of CLL. It has a shot and it very well could happen. I'm actually hoping that it does...because if that happens, sure I'll be late to the party and all you bastards will be celebrating on some beach somewhere, but it will mean certain completion of the Agenda Trial and likely a tesetaxel partnership, at that point the sky is literally the limit.
I hope I haven't discouraged too many people. My PERSONAL risk appetite met its threshold considering my ENTIRE portfolio. If I had other stocks that were performing as well as Genta, even if they were EVEN, I'd stay in this stock because I think it has a shot here shortly. I have to cover some of my losses on other plays as a trader. It doesn't mean that everyone should get out just because I do. Its my personal, holistic portfolio that is bleeding and this offsets my losses.
The DD that's out there hasn't changed, guys. If you are a believer in the approval of CLL then stay in the game. That's the bottom line. You could very, very well become a very wealthy person in a few days.
I'm a believer in the Agenda Trial, which is still a few months out...therefore, I had to take what I have here and bow out for a short time.
Either way, I'll be a buyer when results are released from the FDA on the approval/denial of Genasense in CLL. I'll be chasing like a mofo with approval when the bell rings (helping to skyrocket the price because I WILL buy a solid 2 penny's above the ask), or I'll be buying after the sell-off from those betting on approval in CLL.
I honestly hope that I'm chasing this bad boy down. If that's the case, this stock has no ceiling.
Genta CEO moves ahead despite financial crunch
BIO SmartBrief | 03/03/2009
Genta CEO Raymond Warrell Jr. is still determined to obtain FDA clearance for the company's lead product, cancer drug Genasense, despite the financial difficulties it faces. Warrell said he is working to raise funds to secure approval for Genasense and get Genta out of its cash crisis.
http://www.smartbrief.com/news/bio/storyDetails.jsp?issueid=29C58D72-590B-4D83-8067-DF50A1DC79C7©id=E18EE2FB-F7F3-40B1-92E8-048F7B9989A1&lmcid=
Genta Tries to Cure Itself
http://www.smartbrief.com/news/bio/storyDetails.jsp?issueid=29C58D72-590B-4D83-8067-DF50A1DC79C7©id=E18EE2FB-F7F3-40B1-92E8-048F7B9989A1&lmcid=
BERKELEY HEIGHTS — Raymond P. Warrell Jr. is in a position that few CEOs would envy. The chief executive of Genta Inc., a Berkeley Heights-based biopharmaceutical company, faces a cash crunch stemming from a repeatedly delayed drug launch. Warrell has had to slash more than half of his workforce since December to conserve cash while waiting for the U.S. Food and Drug Administration to approve the lead product developed by his company, which now has some 30 employees.
Moreover, Genta’s 2007 annual report, issued on March 13, carries a “going-concern” warning from Deloitte & Touche, the company’s auditor, that the biotech could run out of cash in the near future. Genta has not turned a profit since it went public in 1991 and has supported itself primarily by issuing stock and incurring debt. Genta is selling off Ganite, a treatment for cancer-related elevated calcium levels that is the company’s only marketed product.
But Warrell, 58, insisted last week that he’s not losing sleep over these matters. “In 2005, similar issues prompted our auditors to issue a going-concern,” says Warrell, who worked as a researcher at New York’s Memorial Sloan-Kettering Cancer Center before moving to Genta eight years ago. “In biotech, you learn to focus on the long term, not on the next calendar quarter.”
The lengthy, expensive drug development cycle that most biotech companies face nearly ensures that they’ll face a near-constant scramble for funds, says John Pennett, director of the life sciences practice at the Edison CPA firm Amper, Politziner & Mattia PC. “A going-concern opinion is to some extent a judgment call by the auditors,” says Pennett, whose firm does not work with Genta.
“We know that biotechs in particular are always trying to raise money for clinical trials, so when they project their cash needs for the next year, we have to consider whether the company actually has the cash in hand, has a firm written commitment, or if it is still searching for the capital. If they’re still hunting for it, then we may have to issue a going-concern.”
“Biotechs are known for their extraordinary ability to either raise cash, or go into turtle mode where they cut their operations and expenses to a bare minimum until they find a funding source,” says Pennett. “So it’s really not unusual for a biotech to get a going-concern opinion one year, yet be able to bounce back later.”
Genta faces some formidable challenges. For one thing, the company continues to struggle with its lead cancer drug, Genasense, whose application for approval was withdrawn in 2004 after an FDA advisory committee turned thumbs down on the treatment.
More bad news struck in 2005 when Aventis terminated a joint development and commercialization project for Genasense, which is designed to treat skin cancer. Genta stock traded around 40 cents a share last week, down from a 52-week high of more than $2.45 in April 2007.
“Unfortunately, biotech companies frequently encounter regulatory obstacles,” says Walter Greenblatt, managing director of Walter Greenblatt & Associates. His Princeton firm works with biotechnology and medical device companies on issues involving strategic planning, raising capital and executing mergers and acquisitions.
“It’s actually uncommon for a new drug application to go all the way through final FDA approval,” adds Greenblatt, who has not worked with Genta.
“Generally, biotech companies raise money and then after awhile they’ll run out and have to try to raise more.”
Warrell says he’s seeking to raise the funds that Genta will need to carry it through the next year or so while he works with the FDA to finally gain approval for Genasense. Meanwhile, says Warrell, the company is moving ahead to develop new drugs.
“We’ve got a diversified investor base and we’re also in discussions with three larger companies about entering into a business partnership that would give us access to their [drug development and marketing] resources,” he says.
“We had hoped to launch Genasense this year, but we may have to look to 2009. We believe, though, that we’ll get the access to the capital we need to accomplish that.”
Another booming day here at ASFX
Gonna run from here...love it!