prr positives & negatives, page-4

"What I challenge and so should all holders, is certain posters, posting information which is clearly false."

More rubbish and baiting from you robhood. You began this thread with a post containing false information.

From an analyst report and posted on Prima's website.......can't be bother adding my own opinion/risks...........

"if we are lucky" what a joke robhood.


Key Risk Factors
The following is not an exhaustive list of potential risks and investors should be aware of the high risk nature of the company.

? Clinical risk – This is the most significant risk given that approval hinges on statistically powered data. The lack of data at this stage on CVac brings this risk into sharper focus. That said, data released to this point has shown promise in both safety and efficacy.

? Trial structuring risk – This was a key issue encountered by Dendreon during the Provenge trial. The risk here is that statistically significant data may not be considered by the regulators if the trial is mis-specified with regard to endpoints. PRR has the benefit of Dendreon going before it and a set of guidelines released by the FDA in 2009 regarding immunotherapeutic vaccines.

? Timing risk – This is in relation to trials that have timing overruns due to inability to recruit suitable patients or operational hiccups regarding manufacturing. These issues can often not be foreseen, however, PRR is using well regarded contract manufacturers.

? Partnering risk – This risk refers to “Big Pharma” finding alternative technology to support prior to CVac achieving marketing approval, allowing Big Pharma to drive a harder bargain which could be to the detriment of shareholder value.

? Capital risk (burn rate) – With the expected initiation of Phase III trials, burn rates are likely to increase from current levels. The company therefore becomes more susceptible to delays or unexpected occurrences.

? Manufacturing risk – This involves the commercialisation of the process as well as the quality of the product being provided. If quality standards drop the product may not work as advertised or cause safety issues.

? Key person risk – The science and expertise required is specialised, the loss of which may delay progress in the clinical program or otherwise hamper the commercialisation prospects of the firm’s products.

? Regulatory risk – This could involve governments changing reimbursement rules, or changing the procedures required to get new products approved, or other changes in legislation that hamper the development or sale of the company’s products.

? Accounting risk – The standards used to account for certain revenue and expense items may change during the life cycle of a particular product, requiring potentially significant accounting revisions.

? Taxation risk – The taxation of certain components of research and development expenditure and other expenses are dependent on current taxation rulings, which may change in future.

http://www.primabiomed.com.au/investor/analyst_report.php