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Smurf I was supposing that (insiders know) with the climb, but hard to tell.
Sheff- looking at the FDA site link you posted - I see Chelsea under the scheduled section for 1/14, then under tentative section I can find no reference of any specific companies, just subject and meeting dates. Am I missing the tentative Company dates on the site somehow?
The adcom listing I normally go by is the biopharm list but it is not always on spot with "tentatives"
Just trying to see if I was missing something on the FDA site relative to specific company mentions.
TIA
T2M
"FDA tentative AdComm schedule for 2014 now available: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm …
These are the companies on tap for an ADCOM: CHTP, ETRM, EXAS, PGNX SLXP, STAA "
CPRX Sheff - any idea on what the LEMS data could mean? Is it a significant malady, or a rare one? I'm totally unfamiliar with it.
"Hopefully they get some news soon and it will be full steam ahead into their catalyst date of early Q2 or April 2014 for their Phase III Firdapse trial.:"
Miles - that drug progression chart is very interesting. #4mm for that one, plus some other DD info in one of your other posts.
This 10Q info lists some of the same info status on it, but it supports what you posted. Thank you. (buc invited me here to stop by and check out catalysts)
Form 10-Q for NEURALSTEM, INC.
12-Nov-2013
Quarterly Report
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We urge you to read this entire Quarterly Report on Form 10-Q, including the" Risk Factors" section, the financial statements, and related notes. As used in this Quarterly Report, unless the context otherwise requires, the words "we," "us," "our," "the Company," "Neuralstem" and "Registrant" refers to Neuralstem, Inc. Also, any reference to "common shares," or "common stock," refers to our $.01 par value common stock. The information contained herein is current as of the date of this Quarterly Report (September 30, 2013), unless another date is specified. We prepare our interim financial statements in accordance with U.S. GAAP. Our financial statements and results of operations as of and for the three- and nine-month periods ended September 30, 2013 are not necessarily indicative of our prospective financial condition and results of operations for the pending full fiscal year ending December 31, 2013. The interim financial statements presented in this Quarterly Report as well as other information relating to our company contained in this Quarterly Report should be read in conjunction and together with the reports, statements and information filed by us with the United States Securities and Exchange Commission or SEC.
Our Management's Discussion and Analysis of Financial Condition and Results of Operations or MD&A, is provided in addition to the accompanying financial statements and notes to assist readers in understanding our results of operations, financial condition and cash flows. Our MD&A is organized as follows:
? Executive Overview - Discussion of our business and overall analysis of financial and other highlights affecting the Company in order to provide context for the remainder of MD&A.
? Trends & Outlook - Discussion of what we view as the overall trends affecting our business and the strategy for 2013.
? Critical Accounting Policies- Accounting policies that we believe are important to understanding the assumptions and judgments incorporated in our reported financial results and forecasts.
? Results of Operations- Analysis of our financial results comparing the three- and nine-month periods ended September 30, 2013 to the comparable period of 2012.
Page 14
? Liquidity and Capital Resources- An analysis of cash flows and discussion of our financial condition and future liquidity needs.
Executive Overview We are focused on the development and commercialization of treatments based on
(i) human neuronal stem cells and (ii) small molecule compounds. We are headquartered in Rockville, Maryland and have a wholly-owned subsidiary in China.
We have developed and maintain a portfolio of patents and patent applications that form the proprietary base for our research and development efforts in the area of neural stem cell research. We own or exclusively license forty-nine (49) U.S. or foreign issued patents and fifty-nine (59) U.S. and foreign patent applications in the field of regenerative medicine, related to our stem cell technologies as well as our small molecule compounds. At times, including in the third quarter of 2012 and first quarter of 2013, we have licensed the use of our intellectual property to third parties.
We believe our technology base, in combination with our know-how, and collaborative projects with major research institutions, will facilitate the development and commercialization of products for use in the treatment of a wide array of neurodegenerative conditions and in regenerative repair of acute disease.
Regenerative medicine is a young and emerging field. Regenerative medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects. There can be no assurances that our intellectual property portfolio will ultimately produce viable commercialized products and processes. Even if we are able to produce a commercially viable product, there are strong competitors in this field and our products may not be able to successfully compete against them.
All of our research efforts to date are at the pre-clinical or clinical stage of development. We are focused on leveraging our key assets, including our intellectual property, our scientific team and our facilities, to advance our technologies. In addition, we are pursuing strategic collaborations with members of academia and industry.
Clinical Programs
Below is a description of our four most advanced clinical programs, their
intended indication, current stage of development and our expected future
development plans.
Future
Development
Program Indication Status Development Plan
NSI - 566 Amyotrophic Lateral Commenced Phase Anticipated to
Sclerosis (ALS) II clinical complete dosing of
trials. the Phase II
clinical trials
during the second
quarter of 2014
NSI - 566 Chronic Spinal Cord Approved to Phase I Trial
Injury commence Phase I expected to
clinical trials. commence during the
fourth quarter of
2013.
NSI - 566 Motor deficits due to Approved to Anticipated to
ischemic stroke commence commence trials
combined Phase during the fourth
I/II clinical quarter of 2013.
trials in China.
NSI - 189 Major Depressive Completed Phase Actively looking to
Disorder Ia, Phase Ib partner development
dosing complete. after Phase Ib
trial. Final data
expected during the
fourth quarter of
2013.
Thank you
T2M
NWBO <link back to annotated chart> up 14% today
ATHX (1/2 pos.) APPY (1/2 pos) Auto profit while out 26% on ATHX and 23% on APPY
Hanging on to the balance for a while. ETRM and ARIA having good days.
BOL
ETRM Hope it is a leak on the ADCOM
ATHX <chart> Hugging upper bolli band chart (displaying no elasticity yet) looks VN. Moving with that raised price target to $10 this seems to be moving vw. jmho
http://bit.ly/1jmJNkA
ETRM <link back> let's hope this bodes well for the pending adcom.
NWBO <annotated chart link back> Holding its own today, looking for it to move north ph1/2 is due and if positive as I suspect it should move well, if not hmmm have a stop loss in there somewhere.
ARIA<annotated chart from 12/20 still valid for the chart portion) <Link back> Oscillators have moved obviously from then, but overall they seem good.
heber - sorry to vent, but that moron is just a despicable creature imho.
Back at ya with the HNY
heber Lmao - that should really help CNBC ratings. Add a total liar and jerk off, who knows NOTHING (ie Fannie and Freddie, "its a perfectly safe investment", right before it went bankrupt. I live in a neighboring state to this perverted mouth piece and total financial idiot.
His favorite replies are:
1. Pls stop interrupting me.
2. No I disagree with that, you are wrong, it is just as I said.
Send this idiot off to Key West, Frisco or Provincetown, but not CNBC! Maybe they got the channel mixed up and it is MSNBC.
I vividly recall him getting caught having his butt buddy Steve Gobie running a male prostitution ring out of Frank's house. Of course nothing was ever done about it, and he continued to get reelected for Fed Orfice.
http://www.free-press.biz/usa/Barney-Frank/Barney-Frank-shame.html
The guy is a disgrace and was part of the 435 Americans who control over 350M of the US population? Wow says a lot about just how far we have come.
Oh well have a good 2014- just looking at boards and saw your post. Ruined my day thanks buddy. lol
WISHING ALL Sheffites, A HAPPY AND PROSPEROUS 2014
t2m
WISHING ALL A HAPPY AND PROSPEROUS 2014
t2m
IDRA <link back annotated chart> 10.24% today still hugging that upper bolli, so no excessive elasticity on the chart at this point. jmho Good solid buy volumes.
Currently at 4.63
NWBO <link back for annotated chart> decent day coming off a dip. Like to see it fight its way back to the 4.20 area which destroys that previous small gap and sets the stage to attack the next resistance area around 4.75 SB a good one to move if the news keeps positive. jmho
NWBO and IDRA both should continue to do well. jmho
Cabos I know the story of you and ABBV from months ago when you told me. I am truly thrilled that it seems to be kicking butt for you it is about $10 25% above where you first spoke to me of it. Even though I flipped it for only a few % months back, I'm hoping you get a home-run, looks like it may happen.
Looks like it retraced a bit but that is normal. BOL
Kudos my friend,
T2M
Good luck with that DITR -
JMHO it seems to have been held down all day by some big asks. I wondered on first glance if it was simply dilution, but the company did an offering in OCT so I rather doubt it. They have 10M COH according to Finviz.
I am inclined to believe that some big players want in at yesterdays pricing. .155
It ran like a scolded cat this morning then suddenly in came either shorts, puts or profit taking, not sure which. But they stole some shares from me before it then bounced up again.
One thing which seems evident is that they had a new issue in OCT it drove the SP down (ref to the chart) as is usually the case, then after a retrace it broke through the start of resistance.
Your guess is as good if not better than mine.
Take care buddy
LJPC some DD on this .155-.165 stock
Source is Sheff:
DD Post on LJPC. The goal of LJPC (Lajolla Pharma) is to eventually uplist to a major exchange and to get larger investors on board. They currently have Baker Brothers, Tang Mngmt, RTW Investments, & Boxer Capital Group. This is an opportunity to follow the Baker Brothers in an early investment. They are the kingpin investors in the biotech space & to my knowledge this is the first time I have seen them make a significant investment in an OTCBB stock. The company has 101m in the float, 220m O/S, and 861m shares fully diluted. The company has strong institutional investing so that risk is still high but is mitigated with the early stakeholders from the restructuring that they have in the company. LJPC Corporate Presentation Oct 2013
http://bit.ly/1cBvuVJ
LJPC sheff's new LOTTO pick for 2014
$heff Member Level Tuesday, 12/31/13 12:33:39 PM
Re: None
Post # of 75255
New Economy & Beginner Portfolio Update.. This stock will do well in 2014 in my opinion & is the OTCBB Wild Card for 2014. I plan to follow the smart money here! The goal of LJPC (Lajolla Pharma) is to eventually uplist to a major exchange(Nasdaq) and to get even more investors on board. They currently have an impressive list of backers at $.07 from their recent financing that eliminated a lot of overhang & debt, & poor share structure in the company. The recent investors via restructuring are impressive in: Baker Brothers, Tang Mngmt, RTW Investments, & Boxer Capital Group. Major DD Posts to follow!
Alert..bought LJPC at $.15 in the New Economy & Beginner Portfolio. Expecting significant gains in 2014 in this one. GCS-100, theLJPC lead product candidate, is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in chronic organ failure and cancer.
Two Catalysts..#1) Plan to initiate Phase 1 clinical trial for the treatment of Hepato Renal Syndrome by the end of 2013/early 2014.
#2) La Jolla Pharmaceutical Company Announces Complete Enrollment of Phase 2 Clinical Trial of GCS-100 in Chronic Kidney Disease - http://yhoo.it/1d6bR6C
Announced that it has completed enrollment of its placebo-controlled, randomized Phase 2 clinical trial of GCS-100 in patients with chronic kidney disease ("CKD"). A total of 121 patients with Stage 3b or 4 CKD were enrolled in the study. The Company expects to announce data on the primary endpoint in April 2014 and the full data package before the end of the second quarter 2014.
LJPC Corporate Highlights
A Phase 2a Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease - Full Text View - ClinicalTrials.gov http://1.usa.gov/1drz8xQ
Large Institutional Ownership..with Baker Brothers being one of those owners.
Full Disclaimer.. http://bit.ly/OlN9DB
BL you made a profit and a good sized one at that, so KUDOS on the trade. As long as it hugs that upper bolli and stays above the dashed line on the chart I am comfortable with it, at some point it should retrace.
Calling exact tops or bottoms is a fools game so you did well, best one can hope to do is average in and average out.
BOL
T2M
IDRA <link back for annotated chart> it is still creeping north.
CUR Ph 1b due 12/31 - what other catalyst am I not seeing? That catalyst is a bit late at this point, unless there is a reason beyond that?
IDRA Wallstreet Cheat sheet article 12/26
http://wallstcheatsheet.com/stocks/idera-pharmaceuticals-presents-a-promising-opportunity.html/?ref=YF
TROV Tough call, with ref to that article you posted - it is not likely to help the SP, depending on how well regarded the author is.
AF writes hit pieces all the time and basically ruins a ton of rallies. Short/put authors tend to make investors leery and shorts richer. Hence many times it is strictly "follow the money", other times it is very legit.
The old saying then applies: investors scare off far 5x easier than investors/enter, hence, in the absence of fact, well regarded short authors like AF tend to succeed in ruining rallies, correctly, or incorrectly for at least a while.
(I hold no position in this security, so I have no dog in the hunt), but you can readily see why either side could want to post these sort of things.
Good luck to you both on this one.
TROV & BIOD Good DD I was looking in my summary catalysts, judging from your post there are a large number not in there; that is unfortunate from a visibility standpoint, since many ref to it for their biotech info.
Thanks again for the detail should be useful to many.
T2M
TROV When you speak of Jan effect for this and BIOD - what are you referring to I can find no catalyst listed? There is an NDA for BIOD Jan of 2015 but I can see nothing else.
Pls define Jan effect.
Thnx
T2M
CUR- Ph 1b due 12/31 - is there anything else?
CPRX Sheff - wondered if I just bought your shares at 2.12? lol
First of 2 lots, if it dips more, and I would suppose it may a bit. Tough to tell since it is now an intraday bouncer over and under the the PP, if it goes back to R-1 for the close I am golden, I think, for the day at least, but if it goes to S2 I may get my second lot lower. Have to see.