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.
everything takes longer in CRMDville. Still waiting on ME sales. Hopefully at least the FDA filing is done on time. GAIN Act status doubles the value of this.
Hopeful as well. We have not had much news since the July approval last year. Sales have more or less been a bust. I doubt we see much traction in EU unless they are able to resolve the Tauropharm issue. The only question that remains is whether there will be a peaceful settlement or eventual litigation. The limbo state we are in currently simply permits TP to continue to infringe at will. I am also curious about the state of the Middle Eastern sales LOI announced several months ago. Have we commenced sales in the region yet??
Not happening in EU until they solve the Tauropharm IP issue. CEO Milby's comments on CC re: same were enlightening. It seems they prefer the carrot to the stick. Of course, it is always good to have both in your hand whilst prodding a stubborn Germanic mule.
Pretty good call. I am encouraged that they are discussing the PATH issue. 5 additional years of exclusivity would be a MAJOR PLUS.
I still believe that these guys will deliver something of value tonight. I am betting sales are mediocre at best but hoping we get news on FDA/label expansion/partnering and/or IP issues.
I am hoping that they update us on Middle East and that we get substantitive news on the FDA side. We could also use an updarte on lavbel expansion and what (if any) progress has been made on IP issue. Friday is drawing near. Let us hope we some sunshine cuts thru the fog.
I think the Neutrolin property is valuable given the potential market size, lack of competitors on the horizon (domestically), and the potential for an additional 5 years of exclusivity. The EU is more irksome. Why the heck they have not filed a lawsuit against the TauroTjhieves (or settled) a year after Mark approval is beyond me. Valuation remains quite cheap. Hopefully they can ink a "name" U.S. partner as some point and the Street may finally take notice.
AWWN--what we really need is someone to elucidate the path forward re: a focused and efficient paradigm shift. Barring that, a deal or two, some FDA news, an update on label expansion, and/or initiation of a lawsuit would sure help get some interest back in this ghost town. : ]
"ZIOPHARM, together with our channel partner Intrexon Corporation, continues to advance a portfolio of immuno-oncology programs, with the goal of enabling a paradigm shift in cancer treatment," said Jonathan Lewis, M.D., Ph.D., chief executive officer of ZIOPHARM. "We continue to work at a rapid pace toward elucidating the enormous potential of the transformative technology driving this pipeline in a data-driven and efficient manner. We also look forward to a number of important, value-creating clinical, preclinical and strategic milestones over the balance of the year and beyond."
I wish there was less elucidating re: paradigm shifting and transformative technology and more substantive action toward a partnering. It is overdue.