Thanks for both those posts Flawed and CL27. On reflection, what...

Thanks for both those posts Flawed and CL27. On reflection, what is really at the core of all this is that the FDA does not want to approve new drugs that take the place of existing drugs which provide the same result to the patient.I would also put forward that the owners of these existing drugs also make a lot of noise and lobby the powers to be that there needs to be substantial proof that Omapro does indeed do what it portrays. Hence the onus is quite squarely on the shoulders of CXS to prove that their drug is really the first use application to sufferers that no longer respond to Gleevac or others.This is why it becomes imperative that they have identified the trial participants in a way that the FDA approves.
Heres why Im optimistic.
The Bloomberg article posted by CL27 seems to indicate that they would recommend approval on efficacy and safety if they were given the chance. At least two of them have stated this openly. Greg also gave this indication at todays conference call. Surely this was the biggest hurdle, as it did rank No. 1 on the list of questions.
Additionally, Greg was very specific in describing the selection process, describing the "sequencing" process they used and stated that this was the correct and accepted method.
So really, the argument comes down to misdiagnosis and whether the selection process was valid. My understanding is that the team conducting these trials are second to none in the industry, so the word sloppy coming from the chairwoman came as a big surprise. But Im not buying it, I reckon theyve done it properly and will work with the FDA to verify it.The market hates delays and this will weigh on the SP in the short term, but those that hang in will get rewarded