This issue will likely grind higher as they file IND. If we get GAIN Act status(+ 5 yrs exclusivity) this is astonishingly cheap. The lawsuit and progress in the EU /Asia are the wild cards but these likely will take time to play out. EU launch has been disappointing to date but I suspect they were under pricing pressure from TP and hence the lawsuit.
The flip side is that FDA is under immense pressure to some of the nasty antibiotic resistant bugs out there---hence the GAIN Act. I agree with your premise overall and still remember when CRMD went thru the drug or device dance with FDA. With GAIN, maybe, just maybe, for once the political winds may be blowing in our favor.
FYI----Griffin (effectively) works for Kirk. They follow Kirk companies almost exclusively so I assume the report was written at Kirk's behest. I own some XON (the parent and epicenter of Kirk's universe) and some ZIOP(his oncology bet). Very hard to figure out which of the dozen or so children will flourish.
Such is the lot of a small company. The important thing is that it is submitted correctly. I remain hopeful here. Today's news takes one giant overhang away. Hopefully we get some wind back in the sails as these guys continue to exhibit competancy.
The German lawsuit is also interesting. I hope CRMD hired pitbulls to eat the TauroTHIEVES legal Rotweilers. I also hope Elliot provides some guidance since they are legal Jedis.
Downside is significant for the Germans IF IF IF we eventually get a positive ruling. I am unsure if there are clawback provisions under German law but will check.
They need to get IND filed and then (hopefully) be garnered PATH status. PATH status would give them significantly more bargaining power in a US partnering negotiation. As for EU----I suspect we don't hear much until the two parties (CRMD and TP meet face to face. It is a shame; I always thought the two would come to an agreement. TP has much to lose and has no shot at US sales . CRMD will spend the money and worst case, be exactly where they are right now (weak EU sales and a potential FDA trial).
Concur. Kirk tends to be very, very patient with CEOs and does not care too much about the day to day share price.
Yes, they do. Taurothieves...sorry Tauropharm is privately held by 3 German nationals. We are not going up against a multinational.
I have been adding as well but Griffin has no weight or credibility. They moved from pushing Lindsey Rosenwald (sp?)stories in the past to today's incarnation of being a defacto PR arm of Intrexon. That said, the energy and food aspects of Intrexon excite me the most. RJ Kirk has a track record of winning in the end and treating public shareholders well. The human therapeutics side of the Intrexon puzzle may take longer to develop. We'll see,
It is bad when an issuer misses a self created deadline. Q3 is almost over and not a peep on ME sales. Not a peep on IND filing. Not a peep on IP issue.
Good weekend all. Maybe next week, or month, or year!
PLEASE tell those crickets to keep it down. I am trying to get some rest. Where are we..... day 28 of the projected IND filing window? Per the PR, terms were agree to in June. Reiterated in subsequent PR and on last CC. Q3 is over in 3 weeks. Do we have sales in the ME yet?? Approved product for 14 months. CMON guys, let's finally hit a deadline and give us an upside surprise. Pretty please.
We need to get some wind back in the sales. The little ship CRMD has been stuck in port for far too many months.
Draconian terms but it seems they are betting on short term pay back. The only way this gets dicey is if we get a delay on FDA or outright rejection on the FDA side. Repayment then will be highly dilutive. Question---why was the financing referred to as secured? What is the collateral?
To be fair, it is also a very small company. Frustrating yet the delays are none too surprising given the history over the past 3 years. SIGH....................
The silver lining is the drug has been de-risked by real world use and I still hold out hope for GAIN Act. inclusion. Perhaps someone will simply buy this out at some point .
CorMedix finalizes Phase 3 study protocol with FDA for Neutrolin
Really unsure why we have not seen an IND filing yet. Very odd, indeed. This remains a great story but they are in danger of losing all momentum in the stock unless we begin to see news flow. As many folks have pointed out, there are numerous potential positives that should come to fruition short term. That said, 1.80 bid speaks volumes as to market perception.
CorMedix, Inc. Finalizes Pivotal Phase 3 Study Protocol for FDA (6/23/2014)
CorMedix announced the progress of on-going discussions with the U.S. Food and Drug Administration for a planned pivotal Phase 3 randomized controlled trial for Neutrolin for use in hemodialysis patients with a central venous catheter. CorMedix worked with the FDA to develop the protocol design for the planned trial for a marketing application. Based on FDA input, the planned Phase 3 clinical trial will be a multi-center, randomized, controlled study conducted in the U.S. and Europe. Dr. Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin Phase 3 program. In addition, CorMedix has earlier submitted detailed information to TUV-SUD for the purpose of advancing our label expansion in the European Union to include oncology, total parenteral nutrition and intensive care patients. Randy Milby, CEO of CorMedix, stated, "The planned Neutrolin pivotal Phase 3 clinical trial is a major milestone which provides us with a clearly defined development and regulatory pathway for Neutrolin, and we would like to thank the FDA for its invaluable guidance throughout this process. "We believe that Neutrolin is well positioned to unlock significant shareholder value."
As always, I remain hopeful!
I am hoping these guys will finally put together a string of good news. IND filing, label expansion, potention GAIN Act inclusion, FINALLY launching sales in ME and maybe even an IP settlement are all in the cards. If they disappoint yet again and cannot get IND filed, I think one must be very suspect of all statements going forward.
Still hopeful here but share price action seems to indicate that Mr. Market is getting impatient.