I've only owned TLON for two weeks (averaged in at .81) I am staying long.
Oncologic Drugs Advisory Committee (ODAC) Meeting
On March 21, 2012, the Company’s Marqibo NDA was assessed at a meeting of the ODAC, which voted seven to four, with two abstentions,
that Marqibo has demonstrated a favorable risk/benefit ratio for the treatment of adult Philadelphia chromosome-negative (Ph-) ALL in second
or greater relapse or that has progressed following two or more lines of anti-leukemia therapy. The ODAC provides the FDA with independent
expert advice and recommendations; however the final decision regarding approval is made by the FDA
You say you're not going to post anymore, and then you post something.
I don't think you were "bashed" - I've seen stronger words, and remember that a few of us have taken a real hit on this co., and can be a little tense on the cusp of an approval (I, for one, have words for that person that "knew" something and recomended this co. to me).
I have a suggestion (probably too optimistic) on your comparision of the 7 - 4 votes. Maybe, this board, knowing the fda denial of a product on a 7 - 4 vote, was a little hesitant to approve; maybe, some that might have been willing to give the benefit of the doubt, in light of the fda prior action, decided to be on the negative side. That would make this 7 - 4 vote all the more solid. And there are no (or few) side effects, for an ailment that offers few if any remedies.
As long as Adam doesn't post anything, I am hopeful. He admitted he was wrong on the board's vote, and perhaps sees that talon is really really prepared this time around. At least I'm hoping that.
glad you take the time to prove what you really are to everyone on this board. Good luck all, Ill keep an eye on the outcome. Id say there is 7% chance of approval.
Yes, Message Boards are idiotic place to seek info or gain insight from intelligent people. Look at all the insults cause I didnt say it is going to get approved.
Im on the fence.. 93% chance its not approved this go around.
I would add that comparing two companies because of the same Adcom vote is as idiotic as reading tea leaves or believing something will be approved because you want it to. That is what is frustrating about your ignorance. With Tlon we are talking about delivery, which is important because currently good and bad cells get killed with treatment. With droxidopa we are talking about a vague disease where the company changed end points half way through study and only followed patients for 2 weeks. I actually believe in droxidopa, but it's like chtp went to the FDA and said approve it because we say so. If 7-4-2 = 7-4-2 is your insight, than you do sound like a basher or an idiot. Just saying
I think what everyone is trying to tell you to do is your own DD. Some of us here have read and re-read every scrap of information, I actually attended the ODAC meeting etc.
You are looking for a stock picking forum with your questions. This ain't it! Go do your homework for your answers.
Sorry, Im not Adam or a Basher. I have questions and provided thoughts, looking for the same in return. Sorry your paranoid or dont like someone that prompts a discussion. Basically, Im doing my own Due Diligence and looking for positive insight into this company.
The point I make to everyone, and those that read this board, is you cant assume the FDA is going to approve cause you want them to. There is a human factor, the FDA generally does not approve a drug the first time it is presented to them. That is a clear and proven fact you cant deny. That is why I asked, is this the first time TLON has presented to them? Small biotechs have a high percentage fail rate with the FDA over the Data and Trial results.
I will no longer post to this board, since its impossible to create unbiased discussion without being called a basher.
I listened to the meeting and was perplexed by the objections that were made by those who voted no; the chairman voiced various concerns that were similar to the no voters, but he ultimately voted yes.
I would take a look at what happened to CHTP for the Northera Drug..TLON is tracking very closely to the same. Advisory committee recommended it 7-4 with 2 obstaining, but Ultimately FDA voted against it. Im not a basher and only following TLON at the moment. Im looking for something to differentiate it from CHTP but I dont see it yet.
It is not an overwhelming recommendation. Still, it was a recommendation, under somewhat difficult circumstances. Further, the Chair of the committee, after asking critical questions, voted for it. A couple abstained, and some have suggested that this was a no vote, but that may be a little too pessimistic.
I find the committee's approval giving the fda cover. If they vote to approve, and something comes out bad later (which I don't hope for), the fda can say, but the . . . approved it.
And, give that this give a little hope, with no real side effects, allows the fda to allow it.