kdalglish14 and a_waywardsailor: Since you know the science about this, would you put your money in this company?
From what you know as of now, would you put your money in this company? Why or why not?
You realize that from 1999-2007, Abbott Labs was doing trials for SIMDAX but after the 2nd trials failed to improve mortality against dobutamine, Abbott Labs decided AGAINST stage 3 Trials because they said it was "not commercially viable" even though the Finnish patent holder of the drug would kick in $20 million to do Phase 3 studies. From your opinion, why would anyone go ahead with Phase 3 studies if the Abbott rejected it with all their expensive doctors and scientists? Is it because this indictation they are testing for is far narrower? Can that be the reason? Or, new science/technology or improved product has something to do with it?
From what you know now, do you feel when the company mentions $600 million market that they are being deceptive as this is being tested for such a small subgroup? That is, even if the test is positive, you can't any where make that much money in this area.
And what is your opinion about the FDA finally lifting the testing for Oxycyte? What do you think the odds are and how long before the FDA gives any answer?
Oxygen Biotherapeutics, Inc., (OXBT) a developer of oxygen-carrying therapeutics, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) results from two series of animal studies designed to address Agency concerns regarding the use of Oxycyte in treating traumatic brain injury (TBI) patients. These studies were conducted to probe both the interactions between Oxycyte and the immune system as well as assess the PFC-based emulsion’s potential to increase the risk of intracerebral hemorrhage (ICH). This research was funded as part of a $2.07 million grant that Oxygen Biotherapeutics has with the U.S. Army who is committed to developing treatments for TBI. Submission of these data represents an important step forward in responding to FDA questions and adding US clinical sites to those already participating in the development of Oxycyte.
In the immunocompetency work, mice were challenged with two of the most commonly encountered types of infections in TBI patients – pneumonia and influenza. Results from these studies clearly demonstrated that Oxycyte has little to no impact on the efficient clearance of these pathogens from the body and, presumably, those removed by similar mechanisms. The no adverse event level (NOAEL) for Oxycyte in the pneumonia and influenza experiments was determined to be 7.2 grams per kg. Exposure of mice to Listeria monocytogenes, a model for aggressive blood-borne bacteria that can lead to sepsis resulted in increased mortality following Oxycyte administration.
Since you are in the business and sense how much demand or possible usage IF THIS DRUG DOES WORK. Do you have a rough estimate of the revenues, especially with this very narrowed indication for testing the drug.
For example, SIMDAX only brings in $60 million in revenues for Orion Pharma of Finland and that is for some 54 European countries marketed to for 14 years. So, what is your guesstimate on possible revenues and if you can back up your guess. Thanks.