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What if CRMD worked (or is working) oncology and UCU in parallel with Hemo? I was bird-dogging DD all weekend and recalled this puppy. One of the reasons I took a nibble on CRMD to begin with.
Thoughts?
https://www.sec.gov/Archives/edgar/data/1410098/999999999718006158/filename1.pdf
Agreed. Though FDA can be brutal, so I’m hoping for the best but in the back of my mind tempering expectations.
One way or the other, I think we’re close to news about FDA meeting. This week or next, IMO.
HOLY CRAP. HE DID IT AGAIN?
SO WHAT’S NEXT FOR OOCHIE GOOCHIE CELLUCCI?
Sorry for the repost. I made a few tweaks. Let’s hope we get some good news in the next two weeks
The following is my opinion and should be used for entertainment purposes only (personally, I’d suggest using as a beer coaster).
THE LPAD PATHWAY.
On last week’s conference call to discuss the statistical significance of the unblinded Neutrolin Phase III data, Khoso and Chew provided shareholders with additional color regarding CRMD’s upcoming meeting with the FDA. CRMD will request their flagship drug, Neutrolin, be approved for hemodialysis patients under the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). CRMD is able to make the request based on two game-changing, data-driven events: (1) the impressive DSMB’s Interim Safety Analysis Report; and (2) the Phase III Lock-IT 100 unblinded top line results, showing highly statistically significant 72% reduction in the risk of CSRBIs over the current standard of care, Heparin.
THE LPAD PRECEDENT.
In September 2018, Arikayce (INSMED) was the first drug to receive approval under the FDA’s new LPAD regulatory approval process. The LPAD designation enabled INSMED to begin commercializing Arikayce in the United States less than two months after approval. Because Arikayce and Neutrolin share many of the same underlying characteristics, Chew believes Neutrolin to be a serious candidate for the coveted LPAD designation:
• Arikayce is a treatment for patients who had very limited options to combat a life-threatening bacteria-driven lung disease; Neutrolin is now a statistically proven treatment to combat life threatening CRBSIs.
• Arikayce LPAD approval was based on results from INSMED’s then-active Phase III CONVERT study, which met its primary endpoint…with statistical significance; Neutrolin Phase III trial—the largest body of evidence ever generated in hemodialysis patients using a catheter lock system—was halted on the DSMB recommendation and backed by highly statistically significant results.
• Arikayce has FDA Fast Track status and is designated as a Qualified Infectious Disease Product; Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product.
AFTER THE MEETING.
CRMD will update the market post-FDA meeting. The following are three outcomes I think possible (with Scenario #2 most likely):
• Scenario #1. The FDA gives CRMD the green light for the use of Neutrolin for hemo, oncology and ICU patients for commercialization. This year.
• Scenario #2. The FDA green lights CRMD’s commercialization of Neutrolin for hemo patients, but will require CRMD to work with the FDA on an additional small scale clinical study (oncology or ICU) to support full approval across all 3 verticals: 1) hemo, 2) oncology and 3) ICU. The FDA requested this of INSMED’s Arikayce as part of the condition for accelerated approval.
• Scenario #3. Complete Doomsday. Nothing gets approved and more trials are required. Unlikely, but worth including (FWIW, I just finished knocking on wood).
OTHER FACTORS TO CONSIDER.
• Major Insider buying last month.
• Elliot Associates, L.P. elevated to Activist Investor status by adding 2,889,430 shares in early January.
• Vanguard Group added 1,000,000 shares.
• Gary Gelbfish relinquishes his seat on the Board. As for a potential replacement? "The Company has identified and is pursuing a number of qualified Board candidates with recognized applicable expertise in drug development and FDA interaction who have indicated they would be disposed to accept an invitation to join the Cormedix Board, with the goal of bringing this process to a successful conclusion in the near future.” Make note of the term ‘near future’.
• All January 10, 2019 SEC filings related to RSU and Stock Option compensation for the Board of Directors (Gary Gelbfish, Janet Dillione, Myron Kaplan, Mehmood Khan Steven Lefkowitz, and Khoso) include RSU & stock option grant language I did not personally see after reviewing 50+ SEC filings from the early part of 2015-2019—a monthly vesting schedule: “These shares consist of RSUs (or Stock Options) granted on 01/10/2019. These restricted stock units will vest monthly with full vesting on the first anniversary of the date of grant, subject to continued service on the board.” If anyone wants to take a look to confirm, that would be great.
RECAP.
• CRMD does not have the infrastructure in place for near-term commercialization.
• CRMD does not have money in place for near-term commercialization.
• CRMD does have the institutional knowledge in place for near-term commercialization.
THE TEA LEAVES AND A HUNCH.
• Neutrolin will be a market disruptor in a billion-dollar industry.
• Neutrolin will likely be the Standard of Care within a very short period.
• The Center of Medicare and Medicaid Services (CMS) ESRD Prospective Payment System. Per Khoso, Medicaid may likely cover Neutrolin—if approved by the FDA—beginning as early as Jan 1, 2020.
• Six months ago, Cormedix delivered a shot across Big Pharma’s bow with the DSMB’s Interim Safety Analysis Report.
• Last week, CRMD delivered a second, larger volley in the form of Unblinded data demonstrating a highly statistically significant 72% reduction in the risk of CSRBIs over the current standard of care, Heparin. You know, the stuff Big Pharma makes billions selling.
• Big Pharma is undoubtedly aware of CRMD’s limitations with respect to infrastructure and capital.
• Big Pharma is also undoubtedly aware that Neutrolin represents an existential threat to the status quo; that is to say, their status quo.
Buyout or partnership, IMO. Soon.
SOURCES.
•https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM610498.pdf.
•http://investor.insmed.com/news-releases/news-release-details/insmed-announces-fda-approval-arikaycer-amikacin-liposome.
•Magic 8-Ball.
THE LPAD PATHWAY.
On last week’s conference call to discuss the statistical significance of the unblinded Neutrolin Phase III data, Khoso and Chew provided shareholders with additional color regarding CRMD’s upcoming meeting with the FDA. CRMD will request their flagship drug, Neutrolin, be approved for hemodialysis patients under the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). CRMD is able to make the request based on two game-changing data driven events: (1) stellar DSMB Interim Safety Analysis Report; and (2) the highly statistically significant 72% reduction in the risk of CSRBIs over the current standard of care, Heparin.
THE LPAD PRECEDENT.
In September 2018, Arikayce (INSMED) was the first drug to receive approval under the FDA’s new LPAD regulatory approval process. The LPAD designation enabled INSMED to begin commercializing Arikayce in the United States less than two months after approval. Because Arikayce and Neutrolin share many of the same underlying characteristics, Chew believes Neutrolin to be a serious candidate for the coveted LPAD designation:
· Arikayce is a treatment for patients who had very limited options to combat a life-threatening bacteria-driven lung disease; Neutrolin is now a statistically proven treatment to combat life threatening CRBSIs.
· Arikayce LPAD approval was based on results from INSMED’s then-active Phase III CONVERT study, which met its primary endpoint…with statistical significance; Neutrolin Phase III trial—the largest body of evidence ever generated in hemodialysis patients using a catheter lock system—was halted on the DSMB recommendation and backed by highly statistically significant results.
· Arikayce has FDA Fast Track status and is designated as a Qualified Infectious Disease Product; Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product.
AFTER THE MEETING.
CRMD will update the market post-FDA meeting. The following are two outcomes I think possible (with Scenario #2 more likely):
· Scenario #1. The FDA gives CRMD the green light for the use of Neutrolin for hemo, oncology and ICU patients for commercialization. This year.
· Scenario #2. The FDA green lights CRMD’s commercialization of Neutrolin for hemo patients, but requires CRMD (as part of the condition of accelerated approval) to work with the FDA on an additional small scale clinical study (oncology or ICU) to support full approval across hemo, oncology and ICU. Such was the case with INSMED’s Arikayce.
OTHER FACTORS TO CONSIDER.
· Massive Insider buying last month.
· Elliot Associates, L.P. is elevated to activist Investor status by upping ownership by 60.9% from 4,744,036 shares to 7,633,466 shares.
· Vanguard Group added 1,000,000 shares.
· Gary Gelbfish relinquishes his seat on the Board. As for a potential replacement? "The Company has identified and is pursuing a number of qualified Board candidates with recognized applicable expertise in drug development and FDA interaction who have indicated they would be disposed to accept an invitation to join the Cormedix Board, with the goal of bringing this process to a successful conclusion in the near future.”
· All 10 January 2019 SEC filings related to RSU and Stock Option compensation for the Board of Directors (Gary Gelbfish, Janet Dillione, Myron Kaplan, Mehmood Khan Steven Lefkowitz, and even Khoso) include RSU & stock option grant language not seen in any previous year—a monthly vesting schedule: “These shares consist of RSUs (or Stock Options) granted on 01/10/2019. These restricted stock units will vest monthly with full vesting on the first anniversary of the date of grant, subject to continued service on the board.”
MY BASELESS, UNRELIABLE, AND HIGHLY OPINIONATED PREDICTION.
Six months ago, Cormedix delivered a shot across the bow to Big Pharma with the interest safety analysis report. Last week Cormedix fired a second. There won’t be a 3rd. Neutrolin is an unparalleled disruptor in a market space worth billions. It will be the Standard of Care within a very short period of time.
Big Pharma won’t compete with CRMD.
Big Pharma will buy CRMD or offer a staggering partnership.
And it will happen much sooner than people think.
I agree. I just hope we hear something about FDA prior to March expiration, otherwise I’ll start moving them to the June.
Good things coming soon, imo.
Good luck to you.
Yeah can’t control that. I think it normalized today. Higher lows mean good things, IMO. Though obviously not immediately.
I believe we’ll close green and reboot next Tuesday.
GLTY
Sorry for some grammar errors. On mobile and can’t edit once sent.
Pfizer owns the market with Heparin. Yesterday they heard what we did: Neutrolin is 72% more effective than their flagship product. Not maybe. Not possibly, but statistically proven.
LPAD, if granted, is going to require a tight window to get the product to market (not a statutory construct, just a hunch...as the other firm given LPAD designation in 2018 had product to market in less than a CY quarter later).
Looked at another way, why would the FDA give the LPAD designation only to have a small 17 person company dither for up to an additional year ramping up production before they could bring it to market. As I’ve said before, they don’t have that kind of muscle. They will need help.
If you are Pfizer or another player champing at the bit to get into the space (or to pair with one of your flagship products in oncology, for example), yesterday you watched as a little boy (or girl) walked into the classroom with an 800 lbs gorilla, named Neutrolin, for show and tell. What then, do they do?
I could be totally wrong. And maybe CRMD goes on the road to raise capital and build an entire infrastructure around then product. That’s at least a year away. At least.
Then why bother with LPAD? The request for designation for an ‘urgent need’ only to wait 12-18 months to deliver said urgent need? That makes no sense. For both CRMD and the FDA.
Anyway, that’s my personal opinion. All the pieces are lining up perfectly except timing. That gap needs to be filled in order to execute a proper roll out.
At least that’s the way I see it.
GLTY.
I am convinced a deal is already in place. PATIENCE.
The mojo will be rising
BOOM TIME POST LUNCH. MARK IT.
Ok. Bye.
BOOM CHAKALAKA!!!
I agree 100%. I think he came in to get them across the finish line. He’s got a princely sum of shares and I hope they truly pay off for all of his hard work.
I expect to see top line numbers PR’d tomorrow. It would make sense on the heals of this announcement.
I think we’re damn close to the finish line.
Got it. Thanks for sharing
Where is it presently? TIA.
Well, I shouldn’t say plenty given we were once a $2.42 in October and the PPS got pummeled. Let’s just hope we get a measured increase over time.
Yeah we have PLENTY of time on the March calls—as long as we get the top line numbers and they are good. Fingers crossed.
I think we’ll be okay on the calls. I think the top line data will tell us everything we need to know.
And hey, never say never:
https://cnafinance.com/newspulse/cormedix-crmd-stock-is-a-buyout-coming/99
What a day!!!
With today’s SEC filings, i’d hazard to guess all the inside buying (and option grants) is about wrapped. Unblinding in next two weeks. And if the data is as good as the DSMB saw during the interim analysts, things will get red hot by Valentines.
BOOM.
Welcome back sir! Glad you are back. Wasn’t sure what happened. Thought it might have been my hard hitting analysis that kept you away, lol.
Holding lots of options so hopeful for the near future! Again, welcome back.
I think it pops on the next 48 hours, imo.
Agree 100 %. Here’s to another Green Day. Only good things happening here
GIDDY UP! Top line results very soon!
I think so. People talk of morning dips every time it moves north, so who knows. I don’t focus on the day trade short term. Been here since April so I’ve seen plenty of up and down—mostly up. It’s going to be a great week, imo. As soon as they release the Top Line LOCK IT 100 efficacy #’s—and if they are good—there is no turning back.
CRMD is on the verge of something very, very special.
Enjoy the ride. :)
GLTY.
Woohooo.
Great news!!! $$$$$$ coming, imo
Agreed. It was getting depressing watching it sink from the 52 week high.
Good things are coming, I like to believe.
They moved to Q1 on the last conf call mid-November last.
Would still be nice to get news about a locked database and efficacy number. Patiently waiting. Hopefully we will hear something very soon.
I hope everyone is buckled in. Q1 is going to be a wild ride.
Let’s have a good day to close out the year.
Wait at you own peril, imo.
Let’s see if it moves north the next couple of days based on your flowery post.
Curious as to the culprits behind the recurring 250K-300K dumps that have walked this down the past 6 weeks.
Yes. It was very interesting.
ROAR.
Sounds like a Christmas miracle!
Hardly, confetti.