DorsetE,
If you liked this yesterday;
We are identifying the next clinical group to establish a data set of patients whose test information can be reviewed by the FDA either in a filing for a 510K device application or as laboratory testing service provided to physicians. A 510K is an approval from the FDA that allows the sale of a diagnostic test in the United States. FDA's review and approval process normally takes one to two years from the start of the clinical trials to final approval. The length of a clinical trial averages a year or more. The data obtained from the trial will form the basis for a 510K filing. Once trials are completed, the data is compiled, the report is written and finally the 510K is submitted for FDA review and approval. FDA rules regarding pharmacogenomics testing are evolving, and management believes that a 510K filing may not be required in order to perform the service. We are seeking additional guidance from the FDA on this issue.
Initial research results will be the basis for our continued development. We must expand our studies and address other aspects of drug treatment performance that will likely be required before OVANOME(TM) could be used in the clinic to assist chemotherapy decisions.
We are developing a clinical trial for OVANOME(TM). We must validate our research findings further through a clinical trial in order to commercialize OVANOME(TM). The trial will use our test to predict trial participants' responses to the Taxol and Carboplatin drug therapy. Our Chief Medical Officer, Dr. Hector Gomez, will lead the clinical development process and expects to enroll 250 patients in the trial. Currently, we have enrolled 100 new patients into this trial for 2005 and expect to add additional patients later in the year. We are also exploring other clinical relationships to increase our patient sample enrollment. We do not anticipate meeting with the FDA until our trials are completed.
You must have liked it just as much last year.
(From march 2004)
We are identifying the next clinical group to establish a data set of patients whose test information can be reviewed by the FDA either in a filing for a 510K device application or as laboratory testing service provided to physicians. A 510K is an approval from the FDA that allows the sale of a diagnostic test in the United States. FDA’s review and approval process normally takes one to two years from the start of the clinical trials to final approval. The length of a clinical trial averages a year or more. The data obtained from the trial will form the basis for a 510K filing. Once trials are completed, the data is compiled, the report is written and finally the 510K is submitted for FDA review and approval. FDA rules regarding pharmacogenomics testing are evolving, and management believes that a 510K filing may not be required in order to perform the service. We are seeking additional guidance from the FDA on this issue.
Initial research results will be the basis for our continued development. We must expand our studies and address other aspects of drug treatment performance that will likely be required before OvanomeTM could be used in the clinic to assist chemotherapy decisions.
We are developing a clinical trial for OvanomeTM. We must validate our research findings further through a clinical trial in order to commercialize OvanomeTM. The trial will use our test to predict trial participants’ responses to the Taxol and Carboplatin drug therapy. Our Chief Medical Officer, Dr. Hector Gomez, will lead the clinical development process and expects to enroll 250 patients in the trial.
So far in the last year Hector has located 40% of the participants he needs to start the trial. Looks like he'll get it going sometime in mid 2006 if he can keep up the torrid pace.
regards,
frog
AI
