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Citrati...any TA on $CYNAF that you find enlightening...tia...hog
BIO-Europe Spring® 2015 Presenting Companies 3/9 - 3/11
http://www.ebdgroup.com/bes/presenters/prs_comps.php
dont think that was a complaint
Nice $IPCI update by doog...
Saturday, 03/07/15 07:04:23 AM
Re: None
Post # of 10256
Timeline on IPCI's next 4 expected FDA ANDA approvals:
-Protonix® accepted by the FDA on Oct 18th, 2010
-No Protonix/Wyeth patent infringement lawsuit filed by Wyeth
-Wyeth completed the FDA's new labeling requirements on Protonix in December 2014 suggesting the FDA is now working with the generic co's like IPCI ensuring the ANDA labeling is upgraded
-Protonix currently at the 53 month mark from the "FDA accepted for filing date" awaiting FDA approval
*pantoprazole (Protonix) treats gastro-esophageal reflux disease (GERD). In the western world between 10-20% of the population affected
-Glucophage®XR accepted by the FDA b4 end of October 2010
-Glucophage has/had no patent litigation to contend with
-Glucophage currently at the 53 month mark from the "FDA accepted for filing date" awaiting FDA approval
*metformen (Glucophage XR) is now believed to be the most widely antidiabetic drug in the world. In the U.S. alone more than 48M perscriptions were filled in 2010
-EffexorXR® accepted by the FDA on May 7th, 2010
-Effexor/Wyeth/Pfizer settlement reached on June 21, 2011
-Wyeth completed the FDA's new labeling requirements on Effexor in December 2014 suggesting the FDA is now working with the generic co's like IPCI ensuring the ANDA labeling is upgraded
-Effexor currently at the 45 month mark from the patent infringement settlement date awaiting FDA approval
*venlafaxine (Effexor XR) In 2007 venlafaxine was the 6th most commonly prescribed antidepressent in the U.S. retail market with 17.2M perscriptions
-SeroquelXR® accepted by the FDA on May 3rd, 2011
-Seroquel/AstraZeneca patent litigation settlement reached on July 31st, 2012
-Seroquel currently at the 32nd month mark from the patent infringement settlement date awaiting FDA approval
Rest of the already filed with the FDA for acceptance ANDA's following the timelines on the above 4 ANDA's:
Lamictaf®XR September 2011
Keppra XR® June 2012
Pristiq® September 2012
Next expected to be filed for acceptance with the FDA ANDA:
CoregCR® which is listed as still under studies
IMNP...roth 3/11
CPXX...http://investorshub.advfn.com/boards/read_msg.aspx?message_id=111134319&txt2find=cpxx
Roth 3/9
financing recently
nice update doog
$CAPR had a 10 million dollar private placement in jan...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=109851911&txt2find=capr
That analysis is why i follow Citrati...nice..i just need to show you how to post a chart...lol...hog
that was a bloody red day for me...5 of 7 went red...as did the market as a whole...hog
That stunk...everything... all day...hog
test
$BNHLF up 15% hitting 0.30...new coverage from a canadian company..and presenting 3/9 at bio-europe.. .http://www.europac.ca/cm/index.php
%BNHLF...up 15% today...hitting 0.30 on volume...hog
Nice day...finished strong...hog
AEZS...out at .81...from .70...wasnt sure why i got in other than momentum and dont have time to investigate further...hog
$TGTX...up 7% currently...and from twitter world...
dougheuring ?@dougheuringaria 2h2 hours ago
@dougheuringaria $TGTX catalysts really pic up later in year Today's news was really nice. Love WEISS's vision
$BNHLF...0.235 is my average...like this one..they do have a 3 month delay in BLA...june now instead of march...hog
MSTX...Rhodey...i probably got out to early...good stock here...hog
TGTX up some with todays news...TGTX is one that moves around a lot...$12.66 was my entry...hog
OT..added more AEZS @0.74...hog
THX $heff my portfolio is up 55% since finding your board in November...hog
AEZS....0.81...hog
MSTX...back out...0.45 to .54...just moving some money...good stock here...best to all...hog
my gf says i have two right feet...lol
member marked...like your dd..hog
AEZS also...
$AEZS...in at .70...hog
$CUR...http://alsworldwide.org/research-and-trials/article/neuralstem-clinical-trials
January 30, 2015
Neuralstem Clinical Trials
By: Dr. Eva Feldman
Phase I (safety) and Phase II (dosage) clinical trials are not expected to determine efficacy, which is ordinarily the subject of Phase III trials. And usually, efficacy suggestions in earlier trials are rarely discussed. In the case of the March 7, 2014 Annals of Neurology Intraspinal neural stem cell transplantation in amyotrophic lateral sclerosis: Phase I trial outcomes, the authors clearly define both the existence and causes of apparent efficacy that are both revealing and promising.
As stated by Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute, Director of Research of the ALS Clinic at the University of Michigan Health System and principal investigator for the NSI-566/ALS trial, "Pre-surgical disease progression rates for the various functional outcome measures were calculated to create slopes for each patient, so that we could determine if post-surgical data points, at 6, 9, 12 and 15 months, improved relative to predicted points. We also did analyses to determine which, if any, functional outcome assessments most closely correlated with the overall ALSFRS-R scores. Comparison of the outcome data to predicted outcome points in group E (patients who received both lumbar and cervical injections) revealed improvements in a significant number of measures at 6, 9, 12 and 15 months post-surgery. Overall, 50% of the patients in the trial showed improvement across multiple clinical measures at the same time points. We also found that a measure of grip strength correlated most closely with the overall ALSFRS-R scores.
We (also) conducted an analysis to identify the most biologically active period of the injected cells for the patients receiving both lumbar and cervical injections. This analysis reveals that the maximal periods of benefit correlate with the two surgical interventions. Importantly, as the 'bell-shaped curve' associated with each intervention is likely due to disease progression, increasing the total cell dose, and applying multiple applications of these stem cells, may increase both the length and magnitude of the potential benefit. We are of course exploring this very dosing regimen in our ongoing Phase II trial."
Karl Johe, PhD, Neuralstem's Chairman of the Board and Chief Scientific Officer, stated, "This peer-reviewed article is the first such report of cervical and dual-targeted intraspinal transplantation of neural stem cells in ALS subjects. We believe our cells offer a means to replace lost cells, provide neurotrophic support, and improve the diseased microenvironment. This study demonstrates these factors, and that the cells and the novel surgical route of administration are safe and well-tolerated. Our ability to directly inject cells into the cervical regions of the spinal cord represents a significant advance in the field of cell therapy.
Richard Garr, Neuralstem's CEO, states, "The initial patient so widely known of who demonstrated great efficacy in the early stages of the Phase I trial is no longer unique. Others have now shown equal or greater benefit from the trials--primarily those who had the highest number of cells injected, who had both lumbar and cervical injections and who were recently diagnosed when initially operated upon." As these (probable) conditions of improved performance are refined and continued in the remainder of the Phase II/IIA trials, it may be a reasonable expectation that more patients volunteering for the Phase III trial, beginning as early as February, 2015 will accrue similar benefit while contributing to the advancement of ALS/MND science. This is very encouraging data.
Under the collective aegis of Drs. Feldman, Boulis, Glass, Rutkove, Cudkowicz, et al, there is clear leadership of clinicians who are experienced and attuned to the nuances of patient condition and behavior as they relate to clinical trial participation. Both the investigators and Neuralstem have shown conservatism and patient safety as their foremost goals.
freakin govt get off your collective asses and review some drugs...hog
well stem cell is the new mary jane stock...hog
like i said i agree..dont see a pullback until we get past these catalysts...
Thx forthe discussion...i too am interested in investors motivations and strategies...i expect a pullback as well only much later...after announcements of new pts..possible pt updates and hopefully updates on possible uplisting...hog
$CTIC...http://www.thestreet.com/story/13028859/2/could-this-biotech-stock-be-the-first-to-break-the-feuerstein-ratain-rule.html
CTI Biopharma's publicly disclosed guidance is for results from the pacritinib phase III study to be announced "late" in the first quarter. Let's assume we get the pacritinib data on March 1. Per the Feuerstein-Ratain Rule, we look at CTI Biopharma's market cap four months back from the estimated phase III data release date, which in this case is Nov. 1, 2014.
CTI Biopharma's market cap on Nov. 1, 2014: Approximately $350 million. That's extremely close to the F-R Rule predicting pacritinib's failure with 100% certainty. The market-cap cut-off for phase III failure is $300 million, but that doesn't take into account any inflationary effects of the biotech sector as a whole over the past two-plus years.
I'm comfortable saying the F-R Rule predicts CTI Biopharma will announce the failure of the pacritinib phase III study in myelofibrosis later this quarter.
I ran the same analysis but shifted the assumed announcement data for study results to March 31 -- as "late" in the first quarter as possible. The result is the same. The F-R Rule predicts pacritinib failure.
The F-R Rule has a perfect track record of predicting the failure of phase III cancer trials when the company running the trial has a market cap of $300 million or less, measured four months before results are announced.
But the shocker alluded to in the headline of this story: CTI Biopharma stands a good chance of being the first company to break the F-R Rule.
What?!?!?!
I wrote about pacritinib in more detail one year ago so I'm not going to rehash the drug's fundamentals. Suffice to say, the drug has shown activity in previous myelofibrosis studies. It's probably not as effective as Incyte's (INCY - Get Report) Jakafi but could be better tolerated due to more benign effect on platelet counts. CTI Biopharma is conducting two phase III studies of pacritinib in myelofibrosis.
The first study -- the one we're discussing here -- is designed with a relatively low bar for success. Pacritinib is being compared against "best available therapy" excluding other JAK inhibitors (meaning no Jakafi.) It shouldn't be too difficult for pacritinib to beat the control arm on the study's primary endpoint -- the percentage of patients with at least a 35% reduction in spleen volume.
[The design of the second phase III study is more challenging for pacritinib, but that's a discussion for another day since patient enrollment isn't complete.]
If fundamental signs point to success for the first pacritinib phase III study, why does the F-R Rule predict failure?
Here's where you have to factor in the toxic history of CTI Biopharma/Cell Therapeutics and the general disdain for CEO Jim Bianco among health care investors.
I've spoken to a few investors this week about pacritinib. They agree the drug appears active and stands a good chance of succeeding in the first phase III study. But asked if they're willing to own CTI Biopharma, they say no. Small sample size, admittedly, but it's a representative view.
In the past year or so, CTI Biopharma has tried to bring in new executives and soft pedal Bianco's role at the company. The company is trying to move beyond its horrible track record of drug development futility and Bianco's self-enrichment schemes to get investors to focus solely on the future opportunity with drugs like pacritinib.
The reality is, Bianco's still a big negative for CTI Biopharma when it comes to the company's credibility on Wall Street. I've long said I welcome the first company to break the F-R Rule. It will be ironic beyond belief and pretty much blow my mind if CTI Biopharma and Bianco -- a guy I said should be fired -- is the company to do it.
BNHLF - .245 hey bigcat...i have been asking the same question and tweeted without any response concerning the delayed BLA...i am new to this fda delays and dealing with this type of small setback...i dont know if it means anything or not...concerning the need to raise money, i am going off what this SA article states but i have a feeling that may change if there is a big investment need d/t the fda changes and 3 month delay..
Thoughts on this one? Will they raise money before the new deadline? If not, it should make another run at 34-36 cents would be my guess.
Telesta has decided to amend its internal objective of filing the MCNA BLA by up to 3 months, from March 31st to June 30th. This decision was taken to accommodate specific recommendations provided by the FDA concerning the Company's manufacturing facility.
http://seekingalpha.com/instablog/13833412-sujan-lahiri/3273535-bioniche-a-home-run-buying-opportunity-in-biotech