fang, page-18

FANG (which has orphan designation for ovarian and melanoma) uses a triad approach which is not only manufactured using each individuals' tumor to assure exposure to the appropriate antigens, but it also activates immune cells and prevents production of proteins (using RNAi) that tumors use to avoid detection by the immune system.

They are initially trialing patients with advanced cancers as it is easier to get special consideration from the FDA if your patients have only months to live and have exhausted all other treatment options. However, they will be targeting patients with earlier stages of cancer, so long as they have a tumour the size of a marble to create enough of the vaccine.

Gradalis believe they can eliminate the need for chemotherapy and want to use FANG to turn cancer into a manageable condition rather than a death sentence. A few of the early patients are still in remission after @ 4 years.

Regarding advancement and progress to registration. If Gradalis are granted BTD they will not necessarily have to do Phase III. In fact, it is not even a requirement to do Phase II if the results are sufficiently good in the eyes of the FDA. Think Gleevec.

Regarding Investor Relations muscle. Gradalis are a small biotech company reliant on grants and a recent cash injection of $25m. Gradalis was formed after the president of the Mary Crowley Cancer Research Centre and their lead scientists started seeing good results in some early trials using RNAi. In fact all of their programs use RNAi. If anything, they are keeping extremely quiet, which is why many on these threads were unaware of them until yesterday. I was aware of them though my investment with Benitec (ASX:BLT), the company who own the core patents to the RNAi Gradalis are using. However, they have declined to take a licence at this stage, and may believe their process is sufficiently different to avoid coughing up at all. IMO they are hoping to eliminate the need for BigPharma involvement to get the drug to commercialisation. If they are granted a BTD they can probably do it as well as the co-owner is from an extremely wealthy family. They were invited to present their preliminary results at the American Society for Gene and Cell Therapy. The media picked it up rather than them actually paying for exposure, like many biotechs do.

I am not suggesting that Neil is trying to pull the wool over anyone's eyes. But is he telling you what you want to hear to prevent concern over a competitors product? Absolutely.