Do you see that, they have to raise cash again in the next 6 months. Not only is this stock falling as they just diluted, they have to do more dilution.
We will need substantial additional funding and if we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate our product development programs.
Developing biopharmaceutical products, including conducting preclinical studies and clinical trials and establishing manufacturing capabilities, is expensive. We expect our research and development expenses to increase in connection with our ongoing activities, particularly as we focus on and proceed with our Phase II-B and Phase III clinical programs and begin clinical trials for our other products. In addition, our expenses could increase beyond expectations if applicable regulatory authorities, including the FDA, require that we perform additional studies to those that we currently anticipate, in which case the timing of any potential product approval may be delayed. Furthermore, pursuant to the terms of the license acquired in the Phyxius asset acquisition, we must pay to Orion a non-refundable up-front payment in the amount of $1 million no later than April 1, 2014. We believe that as of December 16, 2013 our existing cash and cash equivalents will be sufficient to fund our projected operating requirements through June 30, 2014. We will need substantial additional capital in the future in order to complete the development and commercialization of Oxycyte and levosimendan and to fund the development and commercialization of future product candidates. Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. Such funding, if needed, may not be available on favorable terms, if at all. In the event we are unable to obtain additional capital, we may delay or reduce the scope of our current research and development programs and other expenses.
We currently have no approved drug products for sale and we cannot guarantee that we will ever have marketable drug products.
We currently have no approved drug products for sale. The research, testing, manufacturing, labeling, approval, selling, marketing, and distribution of drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, with regulations differing from country to country. We are not permitted to market our product in the United States until we receive approval of a new drug application, or an NDA, from the FDA for each product candidate. We have not submitted an NDA or received marketing approval for any of our product candidates. Obtaining approval of an NDA is a lengthy, expensive and uncertain process. Markets outside of the United States also have requirements for approval of drug candidates which we must comply with prior to marketing. Accordingly, we cannot guarantee that we will ever have marketable drug products.
The development of Oxycyte and levosimendan is subject to a high level of technological risk.
We expect to devote a substantial portion of our financial and managerial resources to pursuing Phase II and Phase III clinical trials for Oxycyte and levosimendan over the next three years. The biomedical field has undergone rapid and significant technological changes. Technological developments may result in our products becoming obsolete or non-competitive before we are able to recover any portion of the research and development and other expenses we have incurred to develop and clinically test Oxycyte or levosimendan. As our opportunity to generate substantial product revenues within the next four to five years is most likely dependent on successful testing and commercialization of Oxycyte and levosimendan for surgical and oxygen delivery applications, any such occurrence would have a material adverse effect on our operations and could result in the cess
Did you notice they lost $2.1 million this quarter? So, how long will that $8.5 million last before another dilution of some sort?
But you must call or nothing is done.
No postponement. They are just doing the planing stages now and won't start enrollment until 3rd quarter 2014 which is the months October, November, December (they did that to deceive people instead of saying the months). And, since the Phase III will last at least 18 months. you are already in 2016 when it ends. Then, the FDA has to take 6 months-12 months to evaluate all the test data so you are already in 2017 before any answer.
That is why people are dumping. IT WAS ALL A PUMP AND DUMP.
Call and inquire Investor Relations below handled by IRTH Communications. The more of us call and complain the more they will do something to put out some kind of positive press release. Like what about the status of the two animal trials sent to the FDA on September 23rd. Or in June the selection of first person to do Phase IIb trials in Israel...what has happened since? Why no status of any other patients? BUT YOU HAVE TO CALL.
Please call me to discuss OXBT, or give me a number and time to call you.
All typos courtesy of Apple and my iPhone !
IRTH Communications, LLC
310 310 4842 Mobile
You #$%$****; you have been saying that for 12 days straight and always wrong.
Newbies, watch out for this paid pumper/dumper. If they are still paying him you will lose. Once he is gone, then it is bottom. It is not anywhere near bottom yet.
why did you tell him not to buy? We need to get out and we need lots of dumb newbies who don't know this was a $1.36 in October and the lying press release made people buy worthless paper.