Tuesday, November 22, 2016 11:13:47 AM
Tampa, of course that is NOT an OPINION.
To come to the conclusion that PPHM has the goods I do not need the market or the II's of which is is commonly know that they 'play' the stocks.
I based myself on the history of clinical trial and other pre-clinical results and the peer reviewed papers etc. For my FACTUAL CONCLUSION that PPHM has the goods I do not need an FDA approval at this time. I need to see that the results yielded by BAVITUXIMAB are what PPHM needed/wanted/expected.
In that I couldn't care less that these results were obtained under either a sabotaged CONTROL ARM (2012) and STILL 60% improvement on SOC. Or, as in SUNRISE, with an ABNORMAL OUTPERFORMING control arm. In both cases the achievements of Bavituximab were NOT AFFECTED. It were the comparison points that were either tempered with or otherwise out of line and BOTH TIMES in the disadvantage of Bavituximab and, MORE IMPORTANTLY, both times in dis accord with the historical data of the control arms that shows that the control arm normally do NOT achieve such outperforming results. Even better, showing that clinical trials run at the same time on the same territory with a same type of clinical care have control arms that confirm that those of the Bavituximab SUNRISE trial were ABNORMAL.
Therefore Bavituximab performs and PPHM has the goods. They just had a dose switching at our 3rd party CRO (CSM in Fargo) and an outperforming control arm keeping them from FDA approval.
To come to the conclusion that PPHM has the goods I do not need the market or the II's of which is is commonly know that they 'play' the stocks.
I based myself on the history of clinical trial and other pre-clinical results and the peer reviewed papers etc. For my FACTUAL CONCLUSION that PPHM has the goods I do not need an FDA approval at this time. I need to see that the results yielded by BAVITUXIMAB are what PPHM needed/wanted/expected.
In that I couldn't care less that these results were obtained under either a sabotaged CONTROL ARM (2012) and STILL 60% improvement on SOC. Or, as in SUNRISE, with an ABNORMAL OUTPERFORMING control arm. In both cases the achievements of Bavituximab were NOT AFFECTED. It were the comparison points that were either tempered with or otherwise out of line and BOTH TIMES in the disadvantage of Bavituximab and, MORE IMPORTANTLY, both times in dis accord with the historical data of the control arms that shows that the control arm normally do NOT achieve such outperforming results. Even better, showing that clinical trials run at the same time on the same territory with a same type of clinical care have control arms that confirm that those of the Bavituximab SUNRISE trial were ABNORMAL.
Therefore Bavituximab performs and PPHM has the goods. They just had a dose switching at our 3rd party CRO (CSM in Fargo) and an outperforming control arm keeping them from FDA approval.
Peregrine Pharmaceuticals the Microsoft of Biotechnology! All In My Opinion. I am not advising anything, nor accusing anyone.
