Well, I expect to hear if this is a "one and done" trial or a multi-part affair They likely submitted proposed trial size etc. to FDA and are simply awaiting response/modifications. Next step is getting it funded. Fingers crossed.
I remain hopeful that these guys have pushed their luck too far. Good news would likely generate an over-sized response.
We never got PFS numbers or anything else substantive. Essentially investors were told "there is no way this drug would be approved in STS" PERIOD. No efficacy data, no safety data, no subset breakout--NADA.
Well, the first test will be to see what kind of partnering deals are out there after CRMD and FDA negotiate trial parameters. This could end quickly if the counterparty(s) realize the market potential of the product and come to the conclusion that owning the global cow is better than owning a portion of milk sales in the U.S.
I hear your frustration,. So many promises of paradigm shifts and partnerships being right around the corner. I think the smallish legacy shareholder base that still remains is officially in the "show me" mode. For the life of me, I cannot figure out why the PICASSO III data was never released. The optimist in me want to think it has some effect on the Breast/ SCLC trial(s). The realist in me fears the trial may have been late to enroll(explaining the extension) of somehow screwed up outside of the U.S..
I think CEO Milby has finally engaged some administrative support. Hopefully they will present a more professional packge going forward. CEO/CFO/CSO here have all been asked to stretch. These guys raised the last 3MM themselves. Hard to ask for much more.
The key here will be if they can partner sales quickly in either middle east or asia. That would give them some breathing room. Also, I am very interested to see who ponies up on the U.S. trial. The "who" will be telling. Outside shot that one of the the counter-parties in U.S. trial negotiations may just decide to take them out. A big boy could quickly ramp sales in EU and would own 100% of U.S. free and clear. Interesting times.
Please never use DREAM TEAM again in reference to ZIOP. See below--
Academic smart is not guarentee of success. I will take Mr. Kirk's business smarts.
NEW HAVEN, CT SEPTEMBER 14 - Newly formed and privately held ZIOPHARM, Inc., headed by chief executive officer Jonathan J. Lewis, MD, PhD announced the members of its senior management team whose positions are effective immediately.
"This is a 'Dream Team' for a cancer products company," said Dr. Lewis, former chief medical officer of Antigenics, Inc. who earlier pioneered cancer research at Yale and Memorial Sloan-Kettering.
"Each has proven himself many times over in his functional area, and together they bring enormous expertise and experience on how to do things right the first time - a rare finding in any business, and an especially important one in a business dedicated to bringing life-saving medicines to market as quickly, carefully, and effectively as possible."
This quote was from 2004----- so much for a lost decade.
Sales in Germany initiated but not yet official--paperwork snafu with regional authorities. FDA meeting seemed VERY positive--potential fast track. Still waiting for PROSL. Commercial partnering progress was the weak point of the call. It is very hard to books substantial sales with 4 guys on the ground in Germany. They need a wholesale channel in Middle East and/or Asia. Management seemed open to questions (as usual). It was nice to have German sales lead on the call. He seemed upbeat. I would grade the call a solid B for organization and effort.
Also, they have no Wall Street sponsor. I have argued that this may just get scooped up one day. Market cap here is silly given the sales potential and approved product already in hand. That said, we still have sellers at .79.
I never count on anything. Much can happen during a journey. That said, this is one of the most compelling risk/reward ratios that I have in years. Honest management----a rarity in small cap medical companies.
The call is in the morning because they want you left coast guys to have to get out of bed extra early!
Seriously, I hope there is some substance to the call. I think if the current management can show progress, they will finally dispel the ghosts of the past. CorMedix 2.0 was launched on July 5th(CE Mark approval). Let's hope these guys take full advantage of their corporate rebirth.
Hopefully we will get some new folks on tomorrow's call. I know that CRMD has been making a PR effort to "get the word out" on this diamand in the rough. It would be nice if an analyst or two showed up to take a look under the hood. Perhaps Mssrs. Milby, Pfaffle, and Lefkowitz will have some good news to share re: both EU sales launch and U.S. trial progress. Fingers, toes, and hooves crossed. Stock is very cheap IF,IF, IF these guys have made any progress on either(or both) front(s).
they will argue that formulation is somewhat different. With high school chemistry knowledge I can tell you that taurolidine and (cyclo)-taurolidine are the same thing. We will see how this plays out. Hopefully Elliot goes into attack mode.
(Sorry---this did not stick in the original post---Yahoo MB are not the mot functional anymore)
CorMedix to Report Third Quarter Financial Results on November 19, 2013
- Conference Call Scheduled for November 20, 2013 at 9 a.m. EST -
. CorMedix Inc. November 15, 2013 11:43 AM
BRIDGEWATER, N.J., Nov. 15, 2013 /PRNewswire/ -- CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardio-renal and infectious disease, today announced that the Company will report financial results for the third quarter ended September 30, 2013 after the close of trading on Tuesday, November 19, 2013.
CorMedix has filed form 12b-25 with the U.S. Securities and Exchange Commission (the "SEC"), and as a result, the deadline for the Company to file its quarterly report on Form 10-Q with the SEC has been extended to November 19, 2013.
CorMedix management will hold a conference call on Wednesday, November 20, 2013, at 9a.m. EST to discuss the results and provide an update on recent business developments. To access the call, please dial 1-866-866-1333 in the United States, and 1-404-260-1421 internationally.
I am long this one. Interesting story. Under-followed and unloved stock. Approved product in EU and US registrational trial launch likely to be announced shortly. They sell a cateter lock product that also has an anitmicrobial component. . My bet is they end up working with with DVA or Fresenius eventually. Please note that stock is quite illiquid and, as mentioned, under-followed.