to our american friends

Once upon a time there was this little Aussie Biotech company that had a dream to develop a leading edge ovarian cancer recurrence immunotherapeutic vaccine. They knew it wouldn’t be easy but they set their goals, kept their focus and kept pushing forward.

Achievements to date (source –Nomura Research)

Feb-06 Announces Phase I data on C-Vac will be published
May-06 Releases Phase 2a data on C-Vac - response rate of 19% (significant) (Australia)
Oct-06 Announces agreement with Burnet Institute to commercialise new developments
Oct-06 Announces discussing strategic options for development of Cvac in Australia with Cell Therapies
Feb-07 PRR secures worldwide commercialisation rights for the Mucin-1 Antigen for dendritic cell based therapies from Biomira
Sep-07 Final Clinical Study report confirms statistical significance of C-Vac Phase 2a trial
Sep-07 PRR announces that it is unable to secure funds to further clinical trials
Oct-07 Announces appointment of Martin Rogers as a NED
Mar-08 C-Vac Gap analysis report received
Oct-08 PRR completes pre IND meeting with US FDA - plans Phase 2 pivotal trial in the US of C-Vac
Jul-09 PRR submits IND with US FDA
Aug-09 FDA grants approval to commence Phase 2B trial of C-Vac (US)
Jul-10 First patient enrolled for US FDA Phase 2B C-Vac trial
Feb-11 US FDA Phase 2B C-Vac trial - initial safety data released
Feb-11 EMA advises that scientific advice for the Phase III trial has been granted
4QCY11 Enrolment for Phase III trial in C-Vac starts (800 patients)
3QCY11 Completion of C-Vac Phase 2B trial

Looking forward
4QCY12 C-Vac Phase 2B trial results available
1QCY13 Full patient recruitment for Phase III study
2HCY13 Interim data on Phase III trial in C-Vac available
2HCY14 Final data on Phase III trial in C-Vac available
2HCY15 US BLA approved for C-Vac
1HCY16 Sales of C-Vac

Now I know that this particular report was written some time ago and timelines / achievements may vary. There are no doubt some I have missed so I invite any posters to add to the list.

There is still talk of a partnership and Prima is still looking at possible options. A US-based partner would IMHO certainly give endorsement to the PRR processes and would assist in getting the product to market.

So call me a ramper if you like, that’s OK I don’t mind and in fact I’m proud of it. I try to stick to the facts though because we can easily get caught up in the day to day chatter, the price fluctuations and high volatility but let’s not lose sight of the end goal – the development of a wonderful product that will help thousands of women around the world and if investors get rich along the way then that’s an added bonus.

Martin and the team are not silly and would be working hard on the public relations aspect in America. Once our friends wake up to the potential of Cvac….well what can I say…Dendron was trading for around US $3 not that long ago and now……..

This company has steadily gone from strength to strength and is slowly ticking off the boxes as they go. It takes about 15 odd years to bring a new drug on to the market and Prima Biomed is certainly heading down the home stretch now.

I wish all long term investors the very best. (Oh, and the traders too)