IntelGenx Technologies Corp (IGXT)

[bUrRpPPP!]

The CRL states that the FDA cannot approve the application in its present form. The Agency requested additional information, but no new bioequivalence study.

“Obviously, we are surprised and disappointed,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “We are committed to addressing the concerns raised by the FDA in the CRL. To that end, we will request a meeting with the Agency as soon as reasonably possible to discuss the scope of the CRL comments to obtain clarification and determine next steps.”

[bUrRpPPP!]

IntelGenx Receives Complete Response Letter from FDA for RIZAPORT® NDA TSX Venture Exchange:IGX globenewswire.com/news-release/2…

[bUrRpPPP!]

Halted pending news....

[SurgeGuy2.0]

How can anyone still be pumping this dilution Scam?

[Stockmaster74]

Fingers crossed.

[bUrRpPPP!]

Big day tomorrow! 3/26 PDUFA good luck all!

[IGXT_GLEN]

https://us18.campaign-archive.com/?e=%5BUNIQID%5D&u=54ecca7eaf77381c47539b8f8&id=d77bdf1bde

[StockItOut]

Just like at Surge Holdings. Similarities to IntelGenx?

[IGXT_GLEN]

Are you intellectually challenged?

[Steve1978]

What's up with the stock drop right before fda approval. Does someone know something we dont?

[SurgeGuy2.0]

SEC INVESTIGATION ! BWAAAA HAAAAA!

[SurgeGuy2.0]

When is the next paid promo bUrRpPP?

[IGXT_GLEN]

Hey SugarGuy... What’s your hard on for Burps-n-poops?

[SurgeGuy2.0]

Holy Wowza! Folks telling others everything is fine are usually the ones dumping behind the scenes.....just saying.......ouch!!!!

[IGXT_GLEN]

Early approval of known NDA’s set to be approved, should be part of a stimulus plan for dealing with this downturn... IMO

[bUrRpPPP!]

We will be just fine...4th time after multiple attempts...even the FDA has a heart!

[IGXT_GLEN]

Congratulations! No more dry powder for me...

[bUrRpPPP!]

Looks like someone got caught in a margin call and had to liquidate 140,000 shares witha market order....wow! Thank you!

[bUrRpPPP!]

Just snatched 25k .24 weeeeeeeeeeeeeeee!

[IGXT_GLEN]

New 52 week low... .3201 Awesome! WTF!

[SurgeGuy2.0]

IGXT Business Model= Lies, pump, Dilution repeat.

[mkt_predictor]

Less than weeks from FDA decision. Keep in mind FDA decision could also come at any time before the March 26 date as well.

[sojieboy]

Because he is a frigging i..diot!

[sojieboy]

Because he is a frigging i..diot!

[bUrRpPPP!]

CBD market

There are not many sectors more crowded these days than cannabis. IntelGenx has two deals ongoing for these type of products. One is with Tilray for a medical cannabinoid that has completed manufacturing scale-up and will launch in 2020. The other is with Tetra BioPharma for a pain-focused dronabinol drug that is already available outside the US and Canada.

In this market, regulatory issues can be a major barrier with this controversial compound. Zerbe explains: “It has been very difficult to keep up with the rapidly evolving and changing legal landscape surrounding edible cannabis products. In order to be able to keep up, we have involved an Ottawa-based consulting firm that specialises in cannabis legislation and the various application procedures.”

In spite of these regulatory complications, oral films are a smart way to differentiate and improve a product in an oversaturated market.
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Whether for crowded markets or drugs with low bioavailability, oral films are an exciting innovation showing potential to provide a win-win for patients and businesses alike.

[bUrRpPPP!]

IntelGenx is in the clinical stage of integrating Montelukast into an oral film with encouraging results showing the ability to restore learning and memory in vivo.

Alzheimer's disease currently has very few treatment options, with none treating the underlying pathophysiology. Therefore, any advancements in this field are important, and the fact that Montelukast is disease-modifying would be of huge significance.

If oral films as a method to increase bioavailability was used for other drugs, there may be more accounts like this, saving drug development from failure or existing drugs that gain a new use.

[bUrRpPPP!]

Currently, IntelGenx is working on or producing 11 different films. Most of these are in partnership with other companies, but Montelukast is the exception. In tablet form, this drug is used to prevent and treat symptoms of asthma and seasonal or year-round allergies.

Certain psychiatric side-effects derived from the drug have led people to seriously consider the neuroprotective aspects. Research then showed that Montelukast could rejuvenate aged brains in animals, suggesting that the leukotriene receptor antagonist may have a similar effect in humans.

A huge barrier to the effectiveness of Montelukast for human use is entering the bloodstream, then crossing the blood-brain barrier. Montelukast does the latter very poorly as a tablet, however, it has been shown to do this easily and in significant quantities when administered as an oral film.

Of the 11 drugs known to be in development by IntelGenx, four specifically target issues connected to the brain. The increase in bioavailability in this area of the body is particularly striking and may be the reason such a high proportion of drugs for the brain are utilising this delivery form.

[IGXT_GLEN]

I hope that they do, I just don’t have any confidence in this management team... I also have zero confidence in Health Canada’s efforts to issue marijuana processing licenses to the 100 of corporate applicants that are waiting. This licensing/enforcement division seems to be at odds with the legislators who have made this industry legal. There were only 3 licenses issued last week and only 1 issued two weeks prior to that! How is this helping the industry’s supply chain and consumers?

[mkt_predictor]

I think they get approval this time. Should pop to $1+ minimum if they do announce FDA approval.

[IGXT_GLEN]

How is a legit FDA PDUFA date (and a Health Canada microprocessing license) considered a “pump and dump”? Pharma’s with imminent PDUFA’s alway generate lots of interest... This one just happens to be less of a speculation due to the previous CRL’s, which have addressed, thereby eliminating some of the possible issues faced with NDA’s. It’s just taken a LONG time to get to this point! Hopefully, IGXT’s Rizaport NDA resubmission is truly “squeaky clean” as Dr. Zerbe has started... IMO

[SurgeGuy2.0]

Another pmp and dmp Scam?

[IGXT_GLEN]

Shhhh! Quiet! You’ll scare it away!

[bUrRpPPP!]

Note that this time there was no pre-inspection requested by the FDA...last CRL was due to manufacturing issues which were fixed...so 4 time a charm!

[yaboy520]

After 7 years and 3 previous rejections, IGXT will attempt for the fourth time to get FDA approval for its migraine drug

[Theboy56]

Yea been down that road before does nothing but screw shareholders more so don't think your doing anything productive!

[SurgeGuy2.0]

Ouch.....Big RED day here....just more proof of this Pump and Dump play.

Where have all the promotors gone?

[SurgeGuy2.0]

Folks continue to file SEC complaints...here is the link for trading fraud and manipulation


https://www.sec.gov/oiea/Complaint.html

Here is the link for anonymous tips that cover fraudulent filings and false statements etc.. also

https://acadia.sec.gov/TcrExternalWeb/faces/pages/accept.jspx?_adf.ctrl-state=zskl0hebe_4&_afrLoop=725363548787341

[SurgeGuy2.0]

No denial of the huge dilution here? No surprise

[SurgeGuy2.0]

PPS tells the true story here 100% SCAM!

[SurgeGuy2.0]

Dilution Machine!!!

Since last 10Q

November 2019: 93,527,473
February 2020: 110,259,653

   

Diluting 6,000,000 a month!!!!! OUCH!!!!!

[SurgeGuy2.0]

Going to get a lot bumpier as the company continues to dump shares to stay afloat given they lost nearly $9M in 2018.

Going Concern
The Company has financed its operations to date primarily through public offerings of its common stock,

https://www.otcmarkets.com/filing/html?id=13726615&guid=CquCUHgk-9Vrxth

[bUrRpPPP!]

It's been a long bumpy road for sure....this will be the 4th pdufa for rizaport. Fortunately it appears the FDA had no need for a (PAI) Pre-Approval inspection this time. The issues from the last PAI were resolved before the new NDA was accepted...The FDA has been extremely hard on IGXT leaving no stone unturned...I am sure the buyers of the offering wanted assurance that this time Rizaport gets the green light. The risk reward is at it's greatest levels now for big returns....keep the faith!

[Tasso9]

I've met them. Shifty and untrustworthy. The worse of the worst. Arrogant chisters

[Tasso9]

Nobody buying horst and his wife's bull----

[nathanial]

Need some volume.

[SurgeGuy2.0]

Why has the stock done a complete retrace? WHOOPSIE DUMP DUMP DUMP!

[SurgeGuy2.0]

IGXT better hire some promoters soon! Stock is ready for new lows...can't sell shares when nobody is buying!

[SurgeGuy2.0]

New Lows! Typical Scam!

[SurgeGuy2.0]

The content and context of the post is Bullshit

[Tasso9]

Redhill hasn't been a partner for quite a while. ??