Biogen expects Amevive in the market Q402 or Q103, which have been their goal all along and they have been on target with each dateline.
The complete opposite: delays galore is the plague of the Xanelim program.
Xanelim was first to all others, then at the time of the Antova program cancellation, Biogen publicly said that they will put all their resources on Amevive, I posted here that xomaDna could loss their lead almost 3 years ago and they did miserably.
Your interpretations of the Complete Response Letter are not in agreement at all with mine ones. It is a clearcut document requesting data, and not extraclinicals (no extra clinical requested at all, which is quite different to Flumist).
Xanelim is at level of erbitux and bpi, not accepted for review, it just happen that Dna was not desperate for application and have the bad publicity of a rejection of application, so they accepted the initial messages (that xoma did not for bpi, neither imcl did for erbitux) and withdraw their ill conceived attemps of EVEN TO APPLY fo a Bla, good judgement indeed, the only different to bpi is that Dna is willing to invest on Xanelim. Of course, the similarities I mentioned are technicalities, not that I believe the product is not effective which it is quite good indeed, actually excellent (small drawbacks similar to Amevive).
Regading the stock prices is simple disconect for Biogen (inappropriately low) and for xoma (inappropriately high) !!! |
