The probabilities for dendreon being approved by the FDA are excellent. Though a lot of this is may be factored into the price already.
Back to PRR , PRR will get a huge and I mean huge ( IMO)
boost as the dendreon story will hit media etc and investors will no doubt be looking for the next dendreon.
Let me tell you why so I dont come across as ramping :
Warning: if Phase IIB trials dont come across positive ( lower probablity than the contrary- reasons explained below) then be prepared for a stall as i believe the team will try to do what dendreon did - read below. If one is willing to take that risk then keep reading......
This is not just a nearology effect but the real possibility that PRR is as efficacious ,if not more as dendreon albeit for different cancers.
PRR will practically be the next dendreon based on in its mechanism of action, its preliminary results and ODS.
If we look at the pathway of dendreon to phase 3 trials which is where it showed overall improvement in survival (the IMPACT trial) most people dont realise that with dendreon two Phase 2 trials failed and successful results only emerged when the data from both failed trials were pooled and analyzed retrospectively.That is not the way FDA likes it hence before the IMPACT trial i.e phase 3 trials none of wall street analysts recommended a buy as they expected poor results. Provenge surprised to the upside
In contrast PRR has shown benefit in its IIa trials and really good benefit in end stage patients ( in announcements ) so we are one step ahead of dendreon if compared directly at same times of development.
PRR additionally has to prove a beneficial outcome in its phase IIb trials ( which dendreon failed during devolopment) , but PRR based on its phase IIa trials it stabilised the CA-125 levels so logically it should for real life patients stabilse their illness thus prolong survival which is the primary outcome which would be enough to convince the FDA .So overall the pathway would be smoother.
Additional advantages :
The team is experienced and the product has support from experts in the field
Low threshold required for FDA approval as the condition is life threatening
Dendreon has laid preliminary steps
Patient lobby groups will spill onto something similar as dendreon for C-vac
Cant directly compare the two but based on pathway to FDA approval , at same time lines C-VAC is one step ahead
Overall benefit for patients is probabaly the most important thing that would come out of it!!
The team are giving us expertise , experience and a great product
the investors need to give support and patience.
thats what brings in the goods!!
Hope this helps , please feel free to scrutinise!
P
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