Hi Greg
I was also at the presentation. I was sitting just beside Martin. Where were you sitting. I also met jason4 who flew in from Melbourne, I suppose.
Greg, you have summed it up well. MR and LT noted that we can't do much about the SP or external factors. But they can achieve the milestones wich they are doing.
Some other points from the presentation and discussion after the meeting are listed below. Sorry for the poor language, I'm at work.
MR thought that DNDN was undervalued and it should rise next year. Sales were still spectacular, although guidance was shocking.
PRRRhas enough cash to spen up to early 2014.
CVAC cost is approx 20k to 30k, and they would sell in Dubai at approx 80k. However, the profits would be insigificant. If women live longer from Dubai sales, it cannot be used to justify that it is beacuse CVAC works. But it gives the company publicity. Many women are waiting for the treatment. Remember the rich people of Dubai have lots of money, so they can even afford to try CVAC in addition to other treatments.
The company has not endeavored to get approval in Australia and other smallar countries, as even if it is approved, the revenues would not be much. The best thing was to get FDA and european approval.
If during phase 3 the results of the people on CVAC are good in percentage terms, the FDA will ask aleter the trial to give CVAC to the entire population, as done for Medivation recently.
The key in Dubai and later in US and Europe too is for oncologists to have confidence in CVAC and prescribe it to patients. MR said that in Dubai, CVAC can even now be administered for other cancers, but he was not sure whether the patient's oncologist would recommend it.
Aftr initial research, the company could have used CVAC to treat any mucin 1 cancer such as lung, pancreas or breast, but the company chose ovarian cancer, as there was no competition other than chemo. Once Phase 3 is successful it can easily be used to other cancers. Some bridging approval would be required, but the main point proven would be that CVAC does not cause harm. MR was confident of the no harm part even now, as the product has been used for 13 years and is made from the person's own cells, so there is no case for rejection by the body. FDA approval is for the Label in this case ovarian cancer when approved. However, 50% of prescriptions in the US are approved by physicians outside label. Even without bridging approval CVAC can be used to treat other cancers if the physicians prescribe it.
Other immunology competitors in the pipeline use different technology, even DNDN's product is inferior to CVAC as they use old technogology.
To cut it short, disreagarding the emotion of the SP, the most important point is that, it must be proven without doubt the CVAC works - ie. it cures cancer. If it does, then it is great for mankind.
Brainybull
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