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So if that was the case...then wouldn't the (smart) thing be to license out immediately? LOL. Right now as it is, Edgemont not doing a very good job with the branded version.
Why would I want to be scaring people?
I'm one of those whose been holding here for a long time... and quite glad it is at least trading at the $0.40s range right now...Quite frankly you have never had anything constructive to say about the stock, since I ve been here. If you know anything about the vendor issue, then say it, otherwise quit it!
A partnership news will not change things, unless you have an approved product...two products were partnered with PAR, and look where we were just a week ago...unless they resolve the vendor issue,this one will just be another hype...it is a good sell the news type of event though...I'm happy this one is back to the 0.40c range. Hopefully stays here! We were told they were working to find a resolution to the vendor issue a long time ago...and here we are still waiting.
none...the rise probably from new investors/interest from yesterday's presentation...will probably dissipate quickly and back to 0.30s...It was the best pop I've seen in a whole year though!
Any mention on Rizaport (migraine)for the FDA issue?
Was hoping Redhill would at least touch on any development or update on the vendor issue. Seems like lost issue from both companies. Would not expect any different from igxt report. It does not look good.
Which means..
this could be in the 0.20 cents soon. How incompetent can this management be? Reminds of AEZS. Another company failure. These two give Canadian companies a bad rep.
what's with the continued paid pumps anyways?
This is the second one in one month...doesn't management get the point...no paid piece is gong to turn this around unless investors start seeing some real changes in the company. new CEO for instance..
in line with being listed...
As one of the worst performing stock of the year. Such a promising 2014, turned from high expectation to going terribly wrong. Nothing went right for this company this year. Nothing!!Puzzling and disturbing. Hoping for a better 2015.. in the meantime more of the same and nothing to look forward for the remaining of the year. it is sad indeed.
And the bleeding continues...
New lows today and no indication of end in sight. Very incompetent decision have been made...Incomprehensible..
Give the guy a break!
He is aging, and does not have the energy to do what you are sking him to do.
It is the reason why the company needed a new CEO. He can't fight nature, and the market is not too keen on that. See where the price is going? It is directly associated with where the direction of the company seems to be headed.
Why is there not a new CEO? I keep asking that question.
Why did the last one leave? It will remain a mistery. But, who would of thought things going this awry.
It is never been so bad around here, and nothing to look forward for the rest of the year makes it that much worst.
thought never say this...but
you may be right...it is more of a possibility now, when cash runs low...it could be back to to the drawing board to raise some cash. hopefully something happens soon to get this one out of danger territory.
Will believe it when I see it. In the meantime, the lame action goes on! Just lame.
Prove it! I don't see anything coming.
Intelgenx updates their presentation to July 2014
http://www.intelgenx.com/investors/presentations.html
that was the impression you were still interested in IGXT...
Otherwise, don't think anyone w/out interst would not be hanging around. I apreciate your honesty!
Is your low eyeballin..
based on your opinion, or charts?
Have you measured your risk/rewards for not being in, and not reaching your entry point target? any updates from the company would make this one pop...IMHO
Gary, hello again! Lol
You have recently stated that you just happy to not be in this stock. But u still can't help take a peak at IGXT board?And if not in, why follow this stock and moderate? Just an observation, that's all! Are you looking for an entry point? Or is there something still interests you about IGXT? Thanks for your response in advanced.
I agree charts suggest other way up
but IBB took a hit today, don't know for what reason, perhaps the IBB is making a correction. IGXT' charts are looking good though.
Planned submission of EMAA and resubmission of NDA
Yes, the train for the upcoming catalysts!
This small cap is catalyst driven, and it jumps very quickly!!!
GLTY
No worries here!
Cash burn for this company is at around 7% at this time.It is a good rate for a small cap's cash burn. The threshold is normally much, much higher when you start considering for more funding. If they were to continue the same rate of cash flow and expenses,they are well funded for around 4 years.
They currently purchase and/or lease, on an as-needed basis, the equipment necessary for performing research and development activities related to their products. I was looking to see in this 10Q what they said about that, and I was clued in by their statement that plans to increase research and development activities are as-needed basis as they enter into partnership agreementst. AS you can see from the date they entered into an agreement with PAR (early this year), their research and development expenses has remained relatelively the same.
But why would you be bitter Gary, you are not in it! Lol
10Q is out and Dilution highly unlikely, 1) they have more cash as of March 2014, than they had in December 2013. 2)They raised money already, explains the $138% increase in cash from same period last year. Cash burn is so little for this co quarter by quarter is ridiculous, and as for revenues, beats most small cap biotech I know.
Gary, I,researched if there were any precedence of hc wainwright upgrades before any dilutions. It looks like there aren't any. It looks to me that if history speaks for it self, we may be safe of any dilutions. Thanks,for,your post, it helps with the due diligence! I think the company has been very conservative in raising cash thru dilution. So far it seems every 2 years. As you know, this is very unlikely in small cap biopharma. And this one is very prudent.
Thanks!
Could get interesting in the next few days!
GLTYA
Looks like point bottom 0.69 - 0.70 range. Few sellers more buyers! !average daily trading volume incraesing!
Also, keep an ear on final results to be reported about the comparative bioavailability by the Canadian clinical research organization (CRO) that conducted the study. Positive results would trigger a planned submission of a European Marketing Authorization Application(EMAA) catalyst event.
GLTYA.
$IGXT..IntelGenx and RedHill Biopharma Report Positive Bioavailability Study Results in Support of Planned European Marketing Application in Q3/2014 for Anti-Migraine VersaFilm(TM) Product
SAINT LAURENT, Quebec, May 21, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company focused on oral drug delivery, today reported, together with RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs, positive results from a comparative bioavailability study with their anti-migraine VersaFilm™ product, an oral thin film formulation of rizatriptan for acute migraines. The study compared the anti-migraine VersaFilm™ product to the European reference drug Maxalt® lingua, marketed in Germany by MSD SHARP & DOHME GMBH, to support the planned submission of a European Marketing Authorization Application ("MAA") for the anti-migraine VersaFilm™ product during the third quarter of 2014.
The results of the study are subject to final quality assurance and an independent study report by the Canadian clinical research organization ("CRO") that conducted the study. The final independent report from the CRO is expected in the coming weeks.
The single-dose, crossover, comparative bioavailability study conducted in Canada followed a positive scientific advice meeting with the German Federal Institute for Drugs and Medical Devices (BfArM) previously announced by RedHill in November 2013. The study, which included 26 healthy volunteers, established the bioequivalence of the anti-migraine VersaFilm™ product and the European reference drug, Maxalt® lingua.
In light of the positive results from the bioavailability study and data from prior clinical studies conducted with the anti-migraine VersaFilm™ product, and subject to various regulatory requirements, IntelGenx and RedHill plan to submit a European MAA during the third quarter of 2014.
IntelGenx and RedHill previously conducted a successful bioavailability study which demonstrated the required U.S. Food and Drug Administration ("FDA") criteria for therapeutic bioequivalence between the anti-migraine VersaFilm™ soluble oral thin film product and the U.S. reference drug, Maxalt-MLT®. Following the successful bioequivalence study, IntelGenx and RedHill announced in 2013 the submission to the FDA and acceptance for review of a New Drug Application ("NDA") seeking marketing approval of the anti-migraine VersaFilm™ product. Following a Complete Response Letter received from the FDA in February 2014, which raised questions primarily related to Chemistry, Manufacturing and Controls ("CMC"), IntelGenx and RedHill recently reported that they believe that FDA approval of the anti-migraine VersaFilm™ product NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Accordingly, the companies continue to work with the FDA in order to address and resolve all remaining CMC questions and to secure a compliant source of the raw material.
About the VersaFilm™ Oral Film Product:
The product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt®. Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms. The worldwide annual sales of triptans were estimated to have exceeded $1 billion in 20131.
The product is based on IntelGenx' proprietary "VersaFilm™" technology. It dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream. The administration method of the oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated at approximately 80% of the total migraine patient population2.
About IntelGenx:
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. More information is available about the company at www.intelgenx.com.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) is an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs for the treatment of inflammatory and gastrointestinal diseases, including cancer and related conditions. RedHill's current pipeline of proprietary products includes: (i) RHB-104 - an oral combination therapy for the treatment of Crohn's disease, with an ongoing Phase III study, (ii) RHB-105 - an oral combination therapy for Helicobacter pylori infection, with an ongoing Phase III study; (iii) RHB-106 - an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals Ltd.; (iv) RHB-103 - an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA under FDA review and a European marketing application planned to be filed during Q3, 2014; (v) RHB-102 - a once-daily oral pill formulation of ondansetron for the prevention of nausea and vomiting, in advanced development stages for multiple indications and, (vi) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol. For more information please visit: www.redhillbio.com
$IGXT - $0.75
Price posted! Thanks!
$IGXT: $heff - are we still allowed to discuss IGXT on your board?
I am aware you have allowed only a few OTCBBs in your board, and IGXT is one of them. There are upcoming catalyst events in line for this company. Let me know if it's ok!
Thank you
Ky
According to your post last Friday (post# 10506), you appear to be so! Your own words not ours!
Sir, only patience may pay off for any stock, not just IGXT...not trying to tell you what to post. You may post whatever you please, just be kind to others and follow the posting rules.
We all know you cannot be the "messenger" of this company...And you are not expected, or attempt to be so either. If you were, who knows what kind of stock market laws you would be breaking.
Things just have a way of running its own course. The company will report when they have to. BE PRUDENT! A post like the one you just posted may have implications for you. You should not be trying to imply you are a "messenger" of the company either (post# 10513).
Specular, we assume your recent negativity and frustration on the stock price may have some motive...We wouldn't think you would be damaging your own prospects of success on the stock if you are currently still holding.
By the way - you had a posting violation a while back discussing off-topic content. Please follow the rules when you post here in the IGXT message board:
"specular
Friday, 04/25/14 08:00:07 AM
Re: ID Supermoney post# 10467
Post # of 10511
Yes clear range here for the foreseeable future - 78-86. If it breaks 86 then next stop will be 92, but both won't be easy.
Once that occurs though this could really fly - and very quickly if they finally give some clarity on the PAR partnership.
Hey ID when's the GC happening with KBLB - your mid-late April prediction is getting pretty tight. I'm with you on the stock, just want to see some movement soon. The paint is dry already - let's move."
Good for you Sir! It doesn't seem like it was much you were holding. only about 30K traded so far. Everyone has their own strategy. While some are selling, some are adding!!
GLTY.
Who are these guys??? 'the ragman/specular'
Sorry for putting you guys on the spot, but let's keep it simple!
None of us are predictors of the stock movement. This is also an OTC stocks - anything is possible.
In this case, the company has proven to be very solid, and IMO “the company” behaves accordingly and even better as if it was a big board company (IMO opinion even more so from ones I know that are in the big boards)
Several points to keep in mind about the company, just pointing out facts:
• It has very little cash burn,
• many drugs in their pipeline,
• one NDA under FDA review,
• another ANDA under FDA review,
• study results of bioequivalence to be reported in June
• Soon thereafter, EMAA submission
• Proprietary rights of technology maintained
• Very conservative of dilutive stock action since inception
• Just obtained government funding from Canada, place of origin
• Approved drug – history of good relations with regulatory entities, such as the FDA.
I don’t know who or what you are trying to fool (respectfully)? others or yourselves. But I don't see an EMPTY GLASS in reference to what you keep opining to each other about.
ALL I SEE IS A HALF FULL GLASS of a company that is getting just started.
In fact, about charts, well I don’t even see any weakness there either, in fact a positive reversal has been in the works. But again the charts are just charts; The price movement also seems to be in a pausing point…very consistent with its historical movement. This stock has held pretty well, and all the other facts are there, enough catalyst to jumpstart again any day. The interest is there, just focus on the half full glass, and you’ll begin to see it.
GLTYA
Based on the news this morning, we now have 2 more significant catalyst events, one in June, and another one in Q3.
GLTA
Catalyst #1: Results of the bioavailability study are anticipated by June 2014.
Catalyst #2: IntelGenx and RedHll plan to submit a European MAA in the third quarter of 2014.
Another one!!! - US Patent Issued to Intelgenx on April 22 for "Controlled-Release Pharmaceutical Tablets"
US Patent Issued to Intelgenx on April 22 for "Controlled-Release Pharmaceutical Tablets" (Canadian Inventors)
ALEXANDRIA, Va., April 22 -- United States Patent no. 8,703,191, issued on April 22, was assigned to Intelgenx Corp. (Quebec, Canada).
"Controlled-release pharmaceutical tablets" was invented by Horst G. Zerbe (Hudson, Canada) and Nadine Paiement (Montreal).
According to the abstract* released by the U.
S. Patent & Trademark Office: "Controlled-release tablets exhibiting excellent storage stability are achieved by granulating a pharmaceutically active agent with a hydroxyalkylcelluose, blending the resulting granules with an extragranular phase composed of a particulate material that provides a sustained-release matrix, and compressing the blend into a tablet form, which may be optionally coated, such as with an enteric coating composition, to provide delayed release and/or to enhance stability of the active agent
http://www.highbeam.com/doc/1P3-3281635801.html
Disagree with your, but we all have a right to disagree..
It is very common during FDA’s review process to ask for clarification of some aspects of the submission. As you can see, the companies have not received any rejections...If it was not an approvable form, the FDA would have issued another CRL...This is a very good sign FDA considers IGXT and Redhill resubmission as an approvable form and as it common in the process to request follow up clarification.
To clarify even more, it is also common that if the resubmission is an approvable form, and as we can see it was evident this was a class 1 resubmission, becasue as for the FDA to find in the resubmission what else they needed to be clarified from the companies, they would have to have had a thorough review. Don't you think?
Once FDA questions have been clarified, FDA will issue a decision. I have seen this happen with many pharmas, and it is usually within weeks after the company’s providing their response.
GLTA
Nice reversal during the day. It held pretty nicely right to the end.
With all this volume today, it is evident, as I said the interest on this one is huge.
Now it will begin to move up rapidly from here… Will not be surprised if there is a small gap up tomorrow during open. These price levels are oversold territory… It’s been oversold for a while now, and it won’t take too long for everyone to realize that today’s action, was an over..over..over reaction to simply an FDA request to clarifications. Another catalyst opportunity has just been created, soon the companies will provide their responses, and the prices will drive much much higher… This current levels can’t hold too long… too much interest here and buying pressure…specially as now that it is so evident FDA began reviewing within the class 1 resubmission timeline, and asking for clarification to warrant approval.
Not a bad close though, as I’m sure not many could digest the news during the market. But tomorrow it’s a different day, and if may you did not buy on the dip today, you probably missed a good chance.
If this was a class 2 resubmission...
you'll be hearing from the FDA 4 months from now - not now..
They did not requested additional efficay data, or clinical trials data, or safety data.
The FDA only requested further clarification.
"FDA has requested from the Companies additional CMC data, which the Companies believe they can supply..."
"The Companies believe that FDA approval of the VersaFilm™ Oral Film Product NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material."
This is no brainer..here it goes some FDA guidance on resubmissions.
B. CLASS 1 RESUBMISSION
A Class 1 resubmission is a resubmission that includes the following items only (or
combination of these items):
1. Final printed labeling
2. Draft labeling
3. Safety updates submitted in the same format, including tabulations, as the original
safety submissions with new data and changes highlighted (except when large
amounts of new information, including important new adverse experiences not
previously reported with the product, are presented in the resubmission it will be a
Class 2 resubmission).
4. Stability updates to support provisional or final dating periods.
5. Commitments to perform phase 4 studies, including proposals for such studies.
6. Assay validation data.
7. Final release testing on the last 1-2 lots used to support approval.
8. A minor re-analysis of data previously submitted to the application (determined by
the Agency as fitting the Class 1 category).
9. Other minor clarifying information (determined by the Agency as fitting the Class 1
category).
10. Other specific items may be added later as the Agency gains experience with the
scheme. These will be communicated through guidance for industry.
100% in desagreement with the recent comments
Considered yourselves notified - FDA condisered this resubmmision a class 1 - this is reason why the companies have got an update from FDA on their hands now. This happened with somaxon with their imsiommia drug resubmission. Afte somaxon submmited a response to the FDA, the FDA responded with an approval within weeks. No need to be alarmed.. if you want to buy on any dips, go right ahead.. if any dips happens, it is going to be shortlived. There are too many eyes on this one... And this one is probably one of the most for sure approvals I have ever seen. With an upside potential that surpasses the $3.
This is a great sign, FDA just told evryone they are reviewing it and have a few more questions to be able to give their OK.
GLTA
CERES still running small trials to convince mills there to take their product. The company is experiencing tremendous cash burn since inception, showing no profits.