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LOL. BIG DAY. should continue to shareholder meeting.
STUNNING the Roth upgrade to $6/share from $1.33.
HOT DAMN!!!
HOT DAMN!!!
I posted hundreds of times beginning at $.0063 that this guy is a massive POS.
OOCHIE GOOCHIE CELLUCI. WAFJ.
Shorts can shake my nuts. FDA news comes out before EOY (which is a possibility, IMO), this goes thermonuclear and shirts will have to drain those 401Ks to cover margin calls.
Nothing would make me happier in this world than watching a good chunk of retirement money being wiped out. Shorts are scum and I hope they get nuked. I think they will.
Yeah, clown statement. FDA at any moment. So no, people won’t be lining up to sell.
LOLOLOL. POST OF THE YEAR!!!
I think Khoso owns over 1.5M shares. You comparison is puny. Sorry.
Over 100,000 shares. That’s a nice statement by management about their faith, IMO. At this point it’s about making sure they have buttoned everything up for the FDA.
NO superfluous PRs, just singular focus on FDA. Let’s hope the numbers support our belief in the product and the process.
Shareholders meeting in less than 2 weeks!
Wow. What a day! So it begins...
Update on CORMEDIX website, re: Patent case. German court to render decision next few months.
Until then, here is a primer on why companies land in Germany. Pro plaintiff. That’s good for CRMD.
https://www.itworld.com/article/2728726/it-management/german-court-system-favorable-for-patent-litigation.html
Follow up #2--more musing and my opinion only about CRMD and the LPAD for hemodialysis patients...
CRMD’s request for the NDA pathway via LPAD will be limited in scope to include Neutrolin to hemodialysis patients with central venous catheters (LOCK-IT-100). While this is the smallest of CRMD's 3 verticals (Oncology/NPS & ICU are the other two), CRMD estimates a potential U.S. market of 660,000 patients (annually). This would require 31,000,000 units (annually). ANNUALLY.
If given the green light by the FDA in Q1 CY19, CMRD would need to be in a position to deliver millions of units next year. Does anyone think CRMD can do this with their existing R&D-based infrastructure (comprised of 19 employees)? I don't.
Only a handful of companies have been given LPAD designation since it rolled out earlier this year. What I am most interested in is the time delta between FDA green light and product to market. If it's a tight window, then it stands to reason they may already have a partner lined up. Why go to the FDA about a great product for LDAP designation, get approval, celebrate, and then realize the 19 people in your company don't have clue about how to get the product to market. It's not a goof on their existing talent base, just not in their immediate wheelhouse.
If that's the case, a partnership might very well be locked down.
Again, complete conjecture and speculation on my part. But I do draw comfort in knowing that the rabbit hole I dove into on Wednesday makes complete sense to me. And it truth, it may be just one of a dozen avenues being explored by the company.
Please, please please let the data be as constant as the Northern start upon unblinding.
http://www.cormedix.com/wp-content/uploads/2018/09/WainWright-Presentation-Sept-6th-2018-Final2-2.pdf
Good luck today
Nice!
One additional note, from the Q3 Con Call:
During the third quarter of 2018, we utilized our aftermarket facility, raising $6.9 million. We raised a further $6.4 million net after commissions through the ATM after September 30, taking advantage of significantly higher stock prices, particularly during the month of October.
I am now of the opinion CRMD's ATM, and not a massive short attack, was the catalyst behind the PPS cratering. If they raised $6,400,000 (after commission), and assume an avg. share price of $1.65, then it's likely 4 million new shares (including commission) were cashed in.
CRMD did the same thing in late July into August after the DSMB interest safety analysis was released. I don't begrudge the need for funding, certainly.
Pure speculation here, but I think the possibility that CRMD might be inclined to fire up the ATM a third time (if positive news comes in the late Jan/early Feb 2019 time-frame) was the primary driver of Elliot's decision to offer the round of funding for $7.9M at a generous $1.50 per share, thereby keeping CRMD afloat through mid-2019 and allowing the PPS to rise organically and unfettered.
And to me, that's a good sign. Elliot is looking for a substantial return on their investment, and they are looking for share price appreciation sooner rather than later. By tapping the brakes on the ATM with the $7.9M funding, CRMD's PPS should appreciate nicely in Q1 and Q2 2019.
Again, just my own musings.
Happy Thanksgiving to all.
As if the CRMD tires haven't been kicked enough, I thought I'd take one last look as we head into the Goldilocks zone. My opinion only, and I am not the greatest predictor by ANY stretch of the imagination. The following is for entertainment value only:
1. The FDA previously guided CorMedix to focus on Phase 3 studies to support the filing of the NDA for Neutrolin. THIS IS AN IMPORTANT NUGGET. Why? FDA anticipates that early and frequent communications between the Agency and sponsors interested in pursuing approval under the LPAD pathway for their products can help reduce overall product development timelines.
2. December Meeting. Khoso’s kinda-sorta (at least to me) head-scratching Q3 con call comment about a “PRE-NDA Meeting” with the FDA. A meeting about a meeting? WTF? This is actually a real thing. They won’t be meeting to discuss, nor submitting all required NDA documentation for the full FDA approval. They will be meeting to discuss CRMD’s request for the NDA pathway via LPAD for Neutrolin limited to hemodialysis patients with central venous catheters based on a single study (LOCK-IT-100) during the presubmission/pre-new drug application (pre-NDA) meeting. This is why CRMD has been working feverishly to clean the database. They need the numbers for the meeting, IMO. On 13 November, CRMD reported it was 97% finished. I bet it’s now complete.
3. CRMD will make the LPAD request at the December FDA meeting. Thereafter, the FDA has 60 days max to approve or deny. For example, if the pre-NDA meeting takes place on Friday, 15 December 2018, the FDA’s decision on the NDA pathway via LPAD will be known to CRMD no later than Monday, February 11th, 2019. That’s why Khoso stated he will report the FDA meeting results in the first quarter of 2019.
4. Prediction Time! At the 11 December 2018 shareholder meeting, CRMD will announce one of two things with respect to the pre-NDA meeting: 1) It already took place, or 2) announce the date in December the meeting will take place. I believe it will be the former. I bet the meeting takes place between 26 November and 10 December 2018.
5. Regarding commercialization and how CRMD can capitalize on their technology, it looks as if Medicare/Medicaid reimbursements may likely include Neutrolin (at some level) at dialysis centers beginning in January 2020.
6. And who knows, if the data is phenomenal (knock on wood), maybe a partner appears between the December FDA meeting and the FDA's NDA/LPAD decision in February (or sooner). Oh, and don't be surprised if, as part of the LPAD approval, they may be asked to perform some type of confirmatory trial. Also, LPAD approval isn't always the silver bullet. It's just a bar of silver, a lighter, a brass casing and some gunpowder. Good enough for me, and plenty good for investors.
In the end, we’ll know by Friday, 8 February 2019 as to whether we hit paydirt or not. At least that's my guess.
If it doesn't fall into place, it's going to be a long cold winter, IMO.
If, however, and it's a big IF, everything falls into place (no small feat for a microcap biotech) and approval is granted, we'll all be loving life. Something to think about as we drift off into Tryptophan heaven today. I like to believe CRMD they went through all the trouble to shut down Phase III these past few months because they truly believe they have numbers. At least that's what I hope.
Time will tell!
Good luck all.
TRAAA LAAAAAA LAAAAAAAAAAAAAAAA!!!
Sources:
a.CRMD Q3 Con Call Transcript
b.Reading tea leaves
c.https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM610498.pdf
d.https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm622048.htm
e.https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM610498.pdf
f.https://www.law.cornell.edu/uscode/text/21/356
g.https://www.appliedpolicy.com/medicare-reimbursement/significant-changes-to-esrd-drug-add-on-pricing-and-quality-measures/
Sorry. That would be “any”, not angry, lol.
Happy Thanksgiving!
That’s from 2015 that angry google search could pull. Thanks anyways.
Question: On last week's conference call, was it Khoso or Chew who said CRMD was hoping to use the FDA's LPAD (Limited Pathway for Antibacterial and Antifungal Drugs) process to roll out Neutrolin? If that is the case, what's the actual down-time between a meeting with the FDA and submission of an NDA. More to the point, is a traditional NDA--which would burn another 3-9 months--even required if a drug is routed through LPAD?
The article below got me thinking...have I been focusing on the wrong approval mechanism?
CRMD seems to meet the threshold requirements for this process? Now, everyone please feel free to set me on fire if I am completely off base.
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm622048.htm
FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation
First drug granted approval under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs, instituted to spur development of antibiotics for unmet medical needs
I see someone’s little minions all over stocktwits because there is no traffic here. No need to post here, truly.
That was disappointing. It’s not shorts doing it, it’s the company. At least at some level.
I am not expecting game changing news tomorrow as we still have another 6 weeks on Q4 and Khoso made it clear the data was a monster to work with.
What I am expecting is some solid guidance and management discussion about earnings, about where they are in the process, about the litigation in Germany next week.
I am also convinced they have been tapping the ATM like madmen (unless the recent drop from the 52 week high is solely the result of concerted and consistent short attacks). I’m not convinced short attacks are what’s entirely at play.
IF my hunch is correct—a big IF, CRMD Is piling up cash, it could mean a number of things, chief among them: CRO-related; money for second Phase III confirmatory trial which may be required; leverage or required cash as part of a partnership/BO; or even CRMD deciding to go it alone (gak!).
Almost outcome is a winner, but may require additional time—e.g. CRMD is asked to perform a confirmatory Phase 3.
I know everyone wants to believe we’re about to hit a grand slam, and hopefully so, but there are outcomes that shareholders must also prepare themselves.
Good luck all, we’re right around the corner to good things, IMO.
No. It wasn’t. LOL. You have a. Somewhat disconnected understanding of CRMD. Perhaps it is best you sold.
Good luck with that.
Oh I see, you sold so now you are hoping to conjure a BS rumor so you can buy in lower, or you took a short position.
Ok bye
Shorts are about to get worked, IMO.
Watch.
To what delay in earnings are you referring?
No Thanks, bra
Lol hope so. I bought more December and March calls. Giddy up! Let’s get some news soon.
Well now, that would be interesting. However, that website is about the sketchiest one I’ve come across since the mid 90’s.
I suppose I shouldn’t judge a book by it’s cover.
Hopefully we’ll hear an update soon regarding the date of the FDA meeting and/or the data unblinding.
If nothing else, I look forward to earnings next week and in particular, management’s discussion.
Good price to dive in. Though not a sub penny, you will do much better than past performance, IMO.
Good luck to you and welcome aboard!
I am very excited to have purchased my first bouncing baby June $2.50 call. That’s right, big daddy warbucks here, though I still believe March and even December 19 calls still have tremendous upside—depending on news.
Based on today’s action, we might be getting out of our five day funk.
GLTA
June ‘19 options now have a $7.50 strike price. That’s a tell, IMO.
A few mins ago, that is.
I went to E*TRADE and found the same thing a few mins. Thanks for sharing.
YW.
Tittilator, shhhhhh. Go CRMD! Big week ahead. Watch.