Right and spot on Robhood
In support of your comments about Prima having the best people on board (mgt, team, advisory), this extract from the 30 Oct 2009 Southern Cross analyst report backs it up well.
Extract:
>>The next stage for CVac
In July 2009 PRR filed its IND application8 with the FDA to conduct a 60 patient Phase IIb clinical trial of CVac in the US. The FDA cleared the trial within 30 days, which is the agencys minimum turnaround time. We see this as indicative of the apparent thoroughness with which PRRs team had done its homework.
We are encouraged about the IND development for six reasons:
1) PRR knows what the FDA wants. Since the trial is being conducted under an IND, its reasonable to say that PRR has a good idea what the FDA expects in an approvable immunotherapy. CVacs Phase IIa trial had not been conducted under an IND, and we understand that the data collected in that trial currently differs from what the agency now requires(9).
(9) Dr Joyce Frey-Vasconcells, former US FDA Director of Cell and Gene Therapy, consulted to PRR on this filing, another indication that PRR has sought to get things right before the first patient is dosed. Half of all late stage ovarian cancer patients gained some benefit from CVac in Phase IIa.<<
This is one of the best and most detailed analyst reports I've seen produced about Prima and I would encourage that people go back and re-read what it has to say, whilst remembering that this was written 6 months ago and we have made positive steps since then ticking more boxes.
Here's another extract I like in support of the reply from MR about patents/IP position.
Extract:
>>PRR doesnt face intellectual property issues for CVac
PRR owns 100% of the technology, without intellectual property issues and with only a modest royalty payable. In March 2004 PRR licensed the CVac technology for use outside Australia and New Zealand to a Canadian company called Biomira, which was developing a similar technology to PRR(16). That agreement was altered in February 2007 with PRR taking back the international rights in return for a modest royalty on sales. This helped clear up the intellectual
property space around MUC-1 and consequently we have no concern about patent litigation in the event of CVacs clinical trial success.
There are no royalties payable to the Burnet Institute. As a result of previous deals with the Austin Research Institute, which took equity in PRR, the company has no royalty obligations to the Burnet Institute, into which the Austin was merged in 2006.
(16) Biomira was developing a product called BLP25, which was MUC-1 wrapped up in liposomes. The fact that the two companies were playing with MUC-1 was potentially an intellectual property issue for PRR, but the Melbourne company, by generating such favourable early stage data with its ex vivo product - BLP25 is by contrast in vivo because liposomes won't crumble under pressure like mannan - had put itself in a favourable position vis-a-vis the Canadian company. Biomira had enabled its product by licensing technology from Imperial College London (see US patent 6,222,020). Biomira is now called Oncothyreon.<<
Had to read that last qualifying point (16) again to get why it favours PRR and not Biomira!
http://www.primabiomed.com.au/investor/analyst_reports_pdf/091117_southern_cross.pdf
cheers
DNP
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