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Replies to #76999 on Biotech Values
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p3analyze

04/30/09 11:26 PM

#77005 RE: jbog #76999

The observation of no more than 5-7 million shares dilution is astute. A couple of hundred million dollars are sufficient to build up manufacutring.

Could you elaborate why CGRB is considered a negative? It has the potential to compete with Provenge in first-line asymptomatic or minimally symptomatic patients, although that trial is yet to be enrolled and is projected not to yield PFS data until Apr 2011, OS data until 2014. http://clinicaltrials.gov/ct2/show/NCT00887198?term=abiraterone&rank=4

The only way imo for it to gain any traction in first-line is if its 2nd-line trial wins on OS in Feb 2011, and the 1st-line wins on PFS in Apr 2011. The probability for that imo is low because of the following:

a. Both first-line and second-line trial enrollment will encounter competitions. 1st-line trial will further be hampered by provenge's approval. Therefore data availability will be delayed, and god knows what other therapy shall emerge to confound the trial. I kind of subscribe the conspiracy theory of why provenge approval encountered so much resistance.

b. PSA is not a reliable predictor for survival, it's doubtful whether the second-line trial will succeed, due to second-line confounding by docetaxel-retreatment. PFS endpont in first-line is notoriously messy and difficult to quantify, unless the CGRB considers PSA as sole type of PFS events. The joint probability of success from both 2nd-line OS and 1st-line PFS is therefore low.

Even if Abiraterone were to make the first-line indication on accelerated approval, one would think Provenge's superior safety and clear win on OS, coupled with short treatment duration would make it a front-runner in first-line. If Abiraterone does turn out a successful PSA killer, then great, there is nothing to stop it from being used after the 3 infusions of Provenge are completed.

Finally, for my edification, shall I interpret what you said below as follows: an ROW infusion should be valued in the same magnitude as the cumulated loss?

>>Dndn has amassed over $570mil in losses so I would expect them to recoup an appropriate portion of that.<< [/]