hey doc, you know what's missing? HOW MUCH DOES IT COST? if it's $2,200 a course like in 2009, well good luck shorts.
just in time for the holidays…and peak season.
if you go to the BCRX website, you'll see you can buy it RIGHT NOW.
ASD Healthcare 1-800-746-6273
Besse Medical 1-800-543-2111
McKesson Plasma and Biologics, LLC 1-877-625-2566
probably have a TV spot ready to go…who knows.
me2 - we've already have signed up distribution with mexico, Israel, and some others. the only problem is, it was a long time ago. whether or not we still have agreement…
you'd think stoney would throw a CC on this, maybe tomorrow.
when it comes to manufacturing, we're not privy to all the information. we also don't know how much is in stock, nor how much work has been done behind the scenes to launch it right away. they (BCRX) has had plenty of time to plan a strong launch… i wouldn't want to be short here...
oh, and one more thing. i'd like to give a special shout-out to that person who for years outlined just how much P is a cash cow. to bad he doesn't have a long position, and has been short at 8 for ages, technicals say he'll never see 9 again...
it's a miracle! congrats to the BCRX team, and all the old timers who have held for so long, and a special thanks goes the MAP, who without a doubt, deserves the most (non-employee) credit.
now, you guys are wondering "hey, why are we down?" not to worry, there are several factors, one of which is the NBI being down over 100 points. second is the fast money "buy the rumor, sell the news" …and lastly, it's the holidays, and the sleazy hedge funds are doing their best to manipulate the PPS.
now for all those people with cash still on the sidelines, GIVE THE SHORTS THE FINGER!
Idelalisib is the fifth new drug with Breakthrough Therapy designation to be approved by the FDA and the third drug with this designation approved to treat chronic lymphocytic leukemia.
Idelalisib’s safety and effectiveness to treat relapsed chronic lymphocytic leukemia were established in a clinical trial of 220 participants who were randomly assigned to receive idelalisib and rituximab or placebo and rituximab. The trial was stopped for efficacy following the first prespecified interim analysis point…
The FDA is approving idelalisib to treat follicular lymphoma and small lymphocytic lymphoma under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials.
of course, but isn't it a possibility that we've been given the status, and now it's just a matter of showing the same results as O1?
at least one analyst thinks so…"We continue to view BioCryst’s HAE portfolio as a pharmacological breakthrough that should ultimately dominate the therapeutic class with peak sales.”
so, does that mean that if they see similar results in O2, the trial can be stopped and 4161 approved?
question- has 4161 been publicly disclosed for "breakthrough" designation?
Will FDA announce when a drug has been granted breakthrough therapy designation?
FDA will not disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designation. Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an IND, or any submissions that have been submitted to the IND, unless it has previously been publicly disclosed or acknowledged per 21 CFR 312.130(a).