welcome to new holders

With the increased interest in Prima Biomed and the expansion in the number of shareholders I can see some new posters to PRR on HC. I thought it might be timely to offer some relevant internet addresses which should hopefully assist new (and possibly long term) holders and reduce the amount of questions asked regarding topics which have already been raised and discussed. This is not having a go at anyone, just offering some assistance. I have also added a summary I made for myself from the recent presentation which I posted a little while ago:

1. Prima Biomed website:
http://www.primabiomed.com.au/index2.php

2. The recent investor presentation (located on Pimas Website)
http://www.primabiomed.com.au/projects/prodDocuments/PRR_Investor%20Presentation_11%20Aug09.pdf

3. US FDA Approvals Process
http://people.musc.edu/~cooperjc/FDAapproval.htm

4. CNN Money - showing Dendreon shareprice and news articles. Not critical to Prima, however is beneficial as they also have a Cancer vaccine for prostate cancer which has completed Phase III trials.
http://money.cnn.com/quote/quote.html?symb=DNDN

Below is my summary of the recent presentation which I attended. It was initially for my own use, however I posted it a little while ago to clarify some issues that were being raised.

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For those who are genuinely interested in Prima and the recent presentation, I add a summary below which I created for myself after attending for future reference. This summary is in my words and how I recall it:

1. Orphan Drug Status is applied for separately and after IND is granted. Expecting to submit and have Orphan Drug Status granted within next six months;

2. Expecting to commence Phase IIb trials by the end of this year (2009);

3. The A$25.5m SpringTree funding was estimated at 2.5 times the amount required to complete phase IIb trials. This amount of funding was arranged to remove any hurdles that may arise and ensure market confidence remained and the share price wasn't unecessarily forced down as it has been previously;

4. Prima are not required to use all or any of the currently arranged funding facilities with Fortrend and SpringTree;

5. Prima can request/apply for funding on better terms with SpringTree or look elsewhere whenever they like;

6. IIb trials expected to take two years;

7. Interim data expected after twelve months into IIb trials (i.e. about 18months time);

8. Phase III trials will start before phase IIb trials are completed, with these trials overlapping each other;

9. Prima have a number of Patents which cover the process of creating and administering Cvac. Some patents expire in 2014 while others expire in 2018. Martin Rogers further explained that being first to market would be a huge advantage for Prima, even if there was a short patent life (e.g. 1.5 to 2 years). This is because this process is so complex, Oncologist would be reluctant to recommend/prescribe alternate generic versions of this treatment to patients. E.g. This is a cancer vaccine, not an over the counter Viagra; (they are expecting Orphan Status though which will extend patent life)

10. Dendreon would not be able to move into Ovarian Cancer treatment with Provenge as their patent is specifically related to a protein or substance located only in the prostate;

11. Cvac is the closest Ovarian Cancer treatment to commercialisation. No other treatment apart from surgery & Chemotherapy is available.

12. There is potential for Cvac to be used by Oncologists for other cancer treatments, not just Ovarian Cancer. Prima will only focus on development and trials with Ovarian Cancer, however there is nothing stopping Oncologist using Cvac for other Cancers once it receives approval.

13. Those shareholders who are concerned about dilution are not thinking about the need to bring this treatment to market. Management are aware of dilution.

14. Regarding the two patients being treated in Melbourne. One patient was too far progressed with their disease and had no immune system. This person had had multiple treatments with Chemo-therapy and passed away after only one injection with Cvac. The other patient is still being treated.

15. The most likely outcome should be a partnering with or takeover by a large Pharmaceutical/Drug Manufacturer, however Prima are not averse to taking Cvac to market themselves, like Dendreon with Provenge.


I hope this all helps

Regards