Longer term, SCLC trial will Pali will have an interim check in(approx.) December.

Long and Hopeful

Disclosure: I am long [[ZIOP]], [[CRMD]].

This is a very interesting speculation with both significant near and long term potential. I have written up a few thoughts on Cormedix after doing significant DD including speaking to both current and former shareholders as well as the new management team. SA does not allow authors to write up issues below $1.00. When the stock moves up(and I believe it will) I will post a much more complete report on SA.

Disclosure: Long CRMD

Disclosure: I am long [[CRMD]], [[ZIOP]].

1) A new management team was installed at year-end

2) 2 recent private placements have given CRMD some much-needed breathing room.

3) Yesterday's 8-K (see below)

The 8-K release likely has more importance than many realize. The company has been on an endless quest to obtain a CE mark in Europe to begin selling its catheter lock product. I believe yesterday's 8-K translates into "they are very close" since the clinical aspect is a go. Essentially, I think it boils down to CRMD needing to create acceptable packaging and regulatory approval will be granted.

CRMD seems to be laying plans for a Euro launch. They have hired Joachim Petrak(the guy who led the German launch of Renagel (Sevelamer)) as sales manager in Europe. Very smart move to hire a local. (see below)

Downside here is balance sheet is very, very thin and they will need to raise $$$ this year. Upside is that current market cap is miniscule.

Additional Considerations: IP issue here could provide upside re: TauroPharm ( a German competitor) See CRMD S-1 for details.

Long and Hopeful Here

Other Events, Change in Directors or Principal Officers

Item 8.01. Other Events.

On March 5, 2013, T&V-S&D, the European notified body managing the CE Mark application for our product candidate CRMD003, or Neutrolin&, informed us that the Medicinal Evaluation Board of the Netherlands, or MEB, gave us a positive response on the clinical aspect of our application. The MEB is responsible for authorizing and monitoring safe and effective medicinal products on the Dutch market and shares responsibility for authorizing medicinal products throughout the European Union.

We are now working on the final packaging for Neutrolin with internationally recognized consultants and a leading packaging systems company to meet T&V-S&D requirements. As a result, we anticipate final approval for the CE Mark certification for Neutrolin during the second quarter in 2013.

Additionally, to lead the commercialization of Neutrolin in the European Union, we have formed a European subsidiary, CorMedix Europe GmbH.

Item 5.02. Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.

(e) On March 6, 2013, our Board of Directors approved an amendment to the vesting schedule of the options granted to our directors and executive officers on December 5, 2012. Such options are described further in our Current Report on Form 8-K filed with the SEC on December 7, 2012. Given the anticipated final approval for the CE Mark certification for Neutrolin during the first half of 2013, such options will now vest as follows: (a) fifty percent (50%) on the date of issuance of the CE Mark certification for Neutrolin in Europe, if the CE Mark approval is obtained on or before June 30, 2013 (as opposed to March 31, 2013 as previously provided by our Board), and (b) fifty percent (50%) on December 31, 2013.

BRIDGEWATER, N.J.--(BUSINESS WIRE)--

CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announced today that it has signed a commercial agreement with MKM Co-Pharma GmbH (http://mkm-europe.com/en/), a European sales, marketing and advertising company with extensive experience in the launch of cardiorenal products. CorMedix entered into this agreement while awaiting the outcome of its application in the European Union (EU) for a CE mark for Neutrolin®, a catheter lock solution (CLS). If approved for use in the EU, Neutrolin will be used for the prevention of catheter related bloodstream infection (CRBI) and maintenance of catheter patency in hemodialysis (HD) patients.

-----------------------------------

To help prepare for a successful launch of the Neutrolin solution, which is planned initially in Germany, MKM hired as a national sales manager Joachim Petrak, who led the German and Central European launch of Renagel (sevelamer), a phosphate binder used to control phosphorus levels in people with chronic kidney disease who are on dialysis. Mr. Petrak has extensive experience with therapeutics (devices and drugs) in the renal dialysis market and strong relationships with European key opinion leaders (KOLs) in this segment.

"We believe our new relationship with MKM, including the addition of Joachim Petrak, will help drive successful sales and marketing efforts for the Neutrolin catheter lock solution in Germany at first, and later in the European Union, in anticipation of product approval," said Randy D. Milby, CorMedix Chief Executive Officer. "Together, we will aim to ensure that Neutrolin becomes widely available in Europe for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease."

"These activities reflect the recent business and management progress we've made at CorMedix," Milby added. "After obtaining the CE mark, we plan to further our efforts for a U.S. FDA regulatory program for Neutrolin and to advance our company and pipeline programs."

Recently, CorMedix reorganized the company bringing in a new management team to enhance its transformation into a commercial organization. Pharmaceutical industry executive Randy Milby was named Chief Executive Officer of CorMedix, supported by Richard Cohen, Chief Financial Officer, and Arthur Morelli, Vice President of Commercial Operations. Morelli brings 30 years of pharmaceutical experience at Du Pont Pharma, Du Pont Merck Pharma, Cardinal Health, Elan Biopharmaceuticals and Solstice Neurosciences. Throughout his career, Morelli has held positions from sales representative to Executive Vice President of Commercial Operations. The new management is focused on efficient execution, and will be the key link between CorMedix's operations in Germany and its Bridgewater, NJ headquarters.

Antony E. Pfaffle, M.D., a CorMedix founder and Chief Scientific Officer, remarked, "The test of a great new product is whether it can raise the standard of care for patients. We believe that, if approved, Neutrolin will reduce potentially life-threatening infections and prevent catheter loss. We are pleased to have achieved this important milestone that we believe will strengthen our ability to launch Neutrolin, once approved in the EU."

Disclosure: I am long [[CRMD]], [[ZIOP]], [[KERX]].

I continue to believe that Palifosfamide will have uses far beyond the STS setting. One day this drug (Pali) could replace IFOS since it is the active metabolite of same.

--------------------------------

ZIOPHARM Oncology Announces Initiation of Indiana University-Sponsored Phase 2 Study of Palifosfamide in Recurrent and Incurable Germ Cell (Testicular and Ovarian) Tumors

RELATED QUOTES

Symbol	Price	Change
ZIOP	4.74

NEW YORK, March 6, 2013 (GLOBE NEWSWIRE) -- ZIOPHARM Oncology, Inc. (ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced the start of a multicenter, single arm Phase 2 investigator-sponsored study of palifosfamide (ZIO-201) in patients with recurrent metastatic germ cell (testicular and ovarian) tumors who have relapsed on initial platinum-based therapy and high dose chemotherapy, or patients who are not eligible for high dose chemotherapy. The study is being conducted at the Melvin and Bren Simon Cancer Center at the Indiana University, led by Lawrence Einhorn, M.D., Distinguished Professor of the Department of Medicine, Division of Hematology/Oncology at the School of Medicine. ZIOPHARM is currently conducting Phase 3 trials of palifosfamide in first-line metastatic soft tissue sarcoma (PICASSO 3) and first-line metastatic small cell lung cancer (MATISSE). Dr. Einhorn is the lead principal investigator for the MATISSE trial. The Company expects to announce topline results from PICASSO 3 the last week of this month.

"While treatments for germ cell cancers are often effective, and five-year survival is high, there remains a population for whom relapse or a lack of tolerability lead to poor prognosis," said Dr. Einhorn. "Palifosfamide is in the same molecular class as ifosfamide, an agent that has transformed the treatment of testicular cancer. Our early experience in Phase 1 testing with palifosfamide in patients with resistant testicular and ovarian germ cell tumors is quite encouraging. Data from the Phase 2 study will inform us of how best to advance the use of palifosfamide in these diseases."

The primary endpoint is response rate (CR+PR) of single agent palifosfamide in patients with refractory germ cell tumors. The secondary endpoints include the duration of remission, progression-free survival (PFS), overall survival (OS) and the safety profile of palifosfamide in patients with germ cell tumors. In this trial, twelve patients will be treated with palifosfamide (150 mg/m² 3 days every 3 weeks for 6 cycles) and, if at least 1 response (RR of >= 8.5%) is observed, enrollment will continue to a total of twenty patients to evaluate response rate of single agent palifosfamide. Additionally, the response rate will be assessed every cycle by RECIST v1.1 and by serum AFP and beta-hCG.

About ZIOPHARM Oncology, Inc.:

ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The Company's clinical programs include:

Palifosfamide (ZIO-201) is a potent bi-functional DNA alkylating agent that has activity in multiple tumors by evading typical resistance pathways. Palifosfamide is in the same class as bendamustine, cyclophosphamide, and ifosfamide. Intravenous palifosfamide is currently being studied in a randomized, double-blinded, placebo-controlled Phase 3 trial (PICASSO 3) for the treatment of first-line metastatic soft tissue sarcoma and is also in a pivotal Phase 3 trial (MATISSE) for first-line metastatic small cell lung cancer. Additionally, the Company is developing an oral capsule form of palifosfamide.

Ad-RTS IL-12 is currently being tested in a Phase 2 study. Ad-RTS IL-12 uses synthetic biology to enable controlled, local delivery of therapeutic interleukin-12 (IL-12), a protein important for an immune response to cancer. ZIOPHARM's DNA synthetic biology platform is being developed in partnership with Intrexon Corporation and employs an inducible gene-delivery system that enables controlled, local delivery of genes that produce therapeutic proteins to treat cancer. This is achieved by placing IL-12 under the control of a proprietary biological "switch" (the RheoSwitch Therapeutic System(R), RTS(R)) to turn on/off the therapeutic protein expression at the tumor site.

Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and a tolerable toxicity profile. It is currently being studied in a Phase 1/2 trial in metastatic breast cancer.

Darinaparsin (ZIO-101) is a novel mitochondrial-and hedgehog-targeted agent (organic arsenic) currently in ongoing studies with Solasia Pharma K.K.

ZIOPHARM's operations are located in Boston, MA, and New York City. Further information about ZIOPHARM may be found at www.ziopharm.com.

Forward-Looking Safe Harbor Statement:

This press release contains certain forward-looking information about ZIOPHARM Oncology that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; financial projections and estimates and their underlying assumptions; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to: whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, and our other therapeutic products will be successfully marketed if approved; whether any of our other DNA-based biotherapeutics discovery and development efforts will be successful; our ability to achieve the results contemplated by our collaboration agreements; the strength and enforceability of our intellectual property rights; competition from pharmaceutical and biotechnology companies; the development of and our ability to take advantage of the market for DNA-based biotherapeutics; our ability to raise additional capital to fund our operations on terms acceptable to us; general economic conditions; and the other risk factors contained in our periodic and interim SEC reports filed from time to time with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2012. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Contact:

For ZIOPHARM
Nicole Jones
ZIOPHARM Oncology, Inc.
617-778-2266
njones@ziopharm.com
Media Contacts:
David Schull or Lena Evans
Russo Partners, LLC
858-717-2310
212-845-4262
david.schull@russopartnersllc.com
lena.evans@russopartnersllc.com----

Disclosure: I am long [[ZIOP]].

We know that the independent monitoring committee recently checked for safety and futility and reported their findings. All good on those fronts. Please note that the trial could not be stopped for efficacy. Only a pre-determined number qualifying events such as disease progression will end the trial . A Lack of sufficient events to halt trial means tumor progression (likely) must be occurring later in some patients(progression would qualify as event). We can assume the the control arm of dox plus placebo is tracking to its historical norm per some of Dr. Lewis' comments so the trial lengthening must be due to another factor. We also know IFOS works in many disease settings but that people are forced off drug due toxicity issues. Since Pali is essentially a derivative of IFOS with fewer side effects, people are likely able to tolerate the drug better and stay on treatment longer.

Others have contended that the delay is simply based on late enrollment. I believe that some of the delay is likely attributed to late enrollment but in a recent web cast, Doctor Lewis (Ziopharm's CEO) said the enrollment was fairly even throughout--NOT back-loaded. Again, Dr. Lewis clearly stated that enrollment was even across trial(NOT back-loaded). I tried to do the math but could only come up with one conclusion--- I believe trial extension can only be the result of the one unknown--ifos effects.

I found this summary on another site. Check out the author's conclusions. he seems to understand the science well and stats the case far more eloquently than I ever ever could. My bet remains that PICASSO III works and one day soon Palifosfamide will replace Ifosfamide in many disease settings. (Note: Ziopharm is also working on a SCLC trial with Pali).

http://propthink.com/ziopharm-palifosfamide-decision-delayed-what-does-this-mean-for-the-likely-outcome/3887

Disclosure: I am long [[ZIOP]].

Kirk needs a win following HALO mis-fire. His ultimate goal is to prove validity of Intrexon platform and IPO his crown jewel.

Shorts remain committed with 10MM share negative bet. Some of this is likely wt. related.

Long ZIOP

Disclosure: I am long [[ZIOP]].