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Sponsors of the bill include
U.S. Senators Bob Corker, R-Tenn., Mark Warner, D-Va., Mike Johanns, R-Neb., Jon Tester, D-Mont., Dean Heller, R-Nev., Heidi Heitkamp, D-N.D., Jerry Moran, R-Kan., Kay Hagan, D-N.C., Mark Kirk, R-Ill., Joe Manchin, D-W.V., Saxby Chambliss, R-Ga., and Mark Begich, D-Alaska, which includes five Republicans and five Democrats from the Senate Banking Committee.
Taken from
http://www.corker.senate.gov/public/index.cfm/housing-finance-reform
that post you replied to was my first post from january 2011. im aware that its a scam. i just wish they would delist this POS already.
they didnt acheive anything. do you really think they are going to press charges against someone while they are running a scam of a company. thats like a drug dealer calling the police because someone stole his drugs.
what a joke. anyone still waiting for a PR needs to check themselves in at the nearest mental hospital. this scam is over, it will be delisted soon. kiss your money good bye.
I agree 20$ by end of August. Institutional ownership is still very low, after approval this increase alone will drive the pps into 20$. Then theres a good chance of a big pharma buyout offer before year end. dont forget EU approval and partnership! 30$ easy by end of year.
I havent been on the board since PDUFA . wow this board has changed i notice alot of new people! Its good to see some of the old posters from when pps was at low 2's still here. Anyway, 1 more week until the big day. good luck all, we will be rewarded very soon.
im new to option trading. I was thinking about purchasing july 8 or july 9 calls on 6/25 or 6/26. what do you think? do you think they will be more expensive then? thanks
actually recent findidngs show the FDA follows the advisory committee about 75% of the time. Also the link you provided is from data collected between 2010-2011, sentiments have changed. also, in the link you provided; if you would scroll down to the bottom the author updated his article in the comments section, he stated:
The following is an update to this article:
At the time of publication, the FDA had not ruled on 7 product candidates (listed as “TBD” in Table 1). Of these 7 product candidates, 6 received favorable advisory committee (AdCom) recommendations. All 6 product candidates were subsequently approved by the FDA and the one with a negative AdCom recommendation was not approved by the FDA.
they met the second endpoint here is a copy and paste from another MB.
From EMEA guidelines:
"4.2.1 Primary endpoints
Weight loss is the primary endpoint. Demonstration of a clinically significant degree of weight loss of
at least 10% of baseline weight, which is also at least 5% greater than that associated with placebo, is
considered to be a valid primary efficacy criterion in clinical trials evaluating new anti-obesity drugs.
Proportions of responders in the various treatment arms could be considered as an alternative primary
efficacy criterion where response is more than 10% weight loss at the end of a 12-month period."
From the Meta Analysis of BLOOM, BLOSSOM, & BLOOM-DM:
"At one year, using Modified Intent-to-Treat with Last Observation Carried Forward analysis (MITT-LOCF) of the integrated results...22.0% of lorcaserin 10 mg BID patients and 17.3% of lorcaserin 10 mg QD patients achieved at least 10% weight loss, compared to 8.3% of patients on placebo."
So, both Lorc QD and BID 10% weight loss are > 5% difference from Placebo (BID: 22.0% - 8.3% = 13.7% QD: 17.3% - 8.3% = 9.0%). I don't see any mention of the % of patients that need to achieve 10% weight loss. All it says is "clinically significant degree of weight loss". Not sure why this is an issue...seems like Lorc clearly meets the EMEA guidelines.
5/14 EMA officially declared lorcaserin as being under review.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/document_listing/document_listing_000349.jsp&mid=WC0b01ac05805083eb
yes there will be very strong support at 5.50 if it breaks through 5.50 it will go straight to 5.0$ and then some. im actually hoping it goes lower i need more shares. i bought some when the secondary offer news came out and everyone was in a panic. wishing i had bought more.
the 5.19 is what the underwriters are getting it for they will sell the shares to institutions for 5.50, the difference they keep. again, this is normal they arent working for free.
cant wait. fatties will be popping these like tic tacs.
9$ TOMORROW!
yep ill be playing the dips from here til June, could be very volatile until FDA. Congrats to everyone who held strong!
profit takers...
no bear raid today BD's were good.but probably profit takers at eod.
if you believe obesity is a disease and people are genetically predisposed youre more inclined to approve a drug for treatment as opposed to those who think exercise is the only cure for obesity.
here is a site that will be providing live feed fom adcom it will cost 140$. link below
http://www.fdalive.com/webcastselect.cfm?meetingkey=1378
its not being covered like vvus was, but a 3rd party is covering it it will cost ya 140$. ill post the link when i find it.
yeah i researched some of them already, as far as I can tell a few of them believe in the obesity/genetics theory.
yes, the BD outlined everything ARNA has already been working on they should breeze through these questions. many people were concerned about surprises in the BD but there was none.
sorry just went over the BD again, colman will be present but not a voting member. great news is Kaul isnt on the panel.
coleman nor kaul on the roster this is excellent news.
BD's look great with no surprises. Today might be very volatile hold onto your shares.
umiak's post summarizes what will happen tomorrow. thanks.
i didnt saying about 12:01 PM... I I said it will probably be released PM tomorrow. PM=Pre market.
hang tight, a big dip in PPS is likely tomorrow; another opportunity to grab more shares.
good luck everyone
documents will probably be released PM tomorrow. Analysts will dissect the BD's and release a pr within an hour of release if not sooner.
thats a great video but it doesnt address the concern im speaking of. and yes, one isnt enough but he can sway some of the panel in the wrong direction. just take a careful took at the last adcom and you will understand where im coming from.
i agree. that same debate is what makes me question the intent of the panel; it has clearly met one of the efficacy requirement, so why did kaul say it has "marginal efficacy". either it meets the requirement or it doesnt.
then you also have at least one person on the panel that is a adamantly searching for ways to deny lorcaserin.
right, but one thing that was repeatedly in question was the "marginal efficacy" issue. As for Arena's data, it hasnt really changed from 2010. It will just be a matter of how well they present the facts and wheather they are prepared to tackle the "marginal efficacy" (whatever that means) with some convincing arguments.
what makes you say its biased in favor of a positive vote? i think its the complete opposite.
actually may 8th the briefing documents are released to the public.. may 10th is judgement day, we will find out the results the same day. ARNA will be haulted on the 10th , no trades will take place until results are released.
im pretty sure those 2.62's were late prints. it happens often in after hour, it doesnt mean anything. sorry...
some of you may already be aware of the change to the adcom panel due to conflict of interest heres a link for those who havent seen it yet
Looks like Daniel Bessesen will be on the panel. he is a "yes" in my opinion. so far its looking good for us that Kaul isnt on the panel, but that could change.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM301728.pdf
good job, we need more people to send emails or letters.
in my previous post theres a link with email address and mailing address to send your support. we need do be as proactive as possible. As shareholders its our responsibility to show support. i hate to say it but even if Lorcaserin doesnt get approved at least we can say we did our part. best of luck.
why is it funny? let us in on the joke
i was on another MB and some are writing letters,emails to the panel. I think it would be in our best interest to send an email on why lorcaserin should be approved, whether its because you are overweight, have a loved one who is overweight etc..
i provided a link with the contact info if you want to send mail or email the info is provided under "contact Information"
everyone please send a letterit will go a long way as the adcom is fast approaching.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm296516.htm
LTG=LoveThatGreen lmao