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Wednesday, June 30, 2010 1:51:33 AM
you wrote:
Ludicrous! It is also difficult to understand why the company is not doing a Phase III instead of yet another Phase II? As anyone with a realistic brain knows, Phase III comes after Phase II, not another Phase II! Even the GEICO caveman knows that! In fact, the correct way to manage and run this company is so obvious, it boggles the mind that it is not being done.
Please remember that only phase 1 had been completed in the US, and while they were waiting for the phase 1 trial to be completed they were able to move on to several phase 2 trials outside of the US to gain valuable data with regards to efficacy. By doing this they were able to determine that Bavi's greatest apparent efficacy may lie in treating lung cancer, which is a very large market, and a potentially easy one to gain access to if our efficacy to date can be repeated (refering to second line NSCLC, which could provide more than a billion a year in revenue in the US alone). With this data they went back to the FDA with both safety and efficacy data, and were able to get a phase 2 double blind placebo control trial with power that could prove that bavi works, and exceeds current treatment. They have also brought on probably the single most experienced person to work with the FDA, being Rob Garnick, to make sure things go smoothly. It has been stated that if there is a sufficient improvement over current therapy, Bavi could be available for use prior to completing a full phase 3 (realize the trial we are running really has all of the standards of a phase 3, but with fewer patients), which means you could have a drug available for use in 2-3 years. I personally do not see how they could position bavi to enter the cancer market faster than they have been doing. The end goal here is a drug on the market, and I personally respect managements strategy wiht regards to this. I also believe that if they can get bavi to market themselves, i will be far richer than if they had done a licencing deal with a 10% royalty a year ago, or even now.
I believe bavi is one of the crown jewels currently being developed, and has potential to be one of the biggest blockbusters to come to market. Peregrine being such a small company, provides huge leverage.
I am however, like most here quite frustrated at the current share price, but realize that dilution now, perhaps enough to get the going concern removed, will quickly be rewarded if we are holding full rights to this drug two years from now with phase 2b results showing results that everyone here who follows the science believes is possible.
I bought shares in this company more than five years ago when I was 21. My holdings have gone from 1000 to 8500, and I add from time to time, with the goal of acquiring 20000 before it takes off. If bavi fails, my investment will likely be worthless, and I will move on. If it is successful I might be retired at 30. Time will tell, the noise in between will only provide buying opportunities for those with the balls and the stomach.
Good Luck ;)
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