V1,
None of the brokerage analyst, buy side and sell side thought that NDA Velcade will be before PIII is completed. None!
All those brave analysts were betting on IMCL NDA Erbitux based on PII.
What they do is that they are messing around like blind rats. Bottom line, who cares what they wrote in reports?
After PII MLNM has end-of-trial discussion with FDA, and this was after PIII started (with different pts population than PII was conduced). Will FDA give MLNM GO signal for nothing? Or maybe MLNM is blind and stupidly, like IMCL, playing with FDA?
PII trials show that 40-50% of the third line MM (NO option at all) did have clear benefit from Velcade. Something that Irresa and Erbitux can only dream about. This was not uncontrolled trial. Selection of the pts was rigor, and it did not have control arm because there were not any option left. The problem may be small numbers of the pts in trial, but this should not be a problem if they ask for appropriate drug label.
<<However, 21% of patients had to discontinue taking the drug because of an adverse safety event.>>
That is incorrect. 7% discontinue from drug adverse events. 14% discontinue from disease comorbidity factors, not related to drug.
None claim that Velcade is without adverse events. However show me only one effective cancer drug without serious adverse events and I will reduce probability of the Velcade approval to 50%.
<<I did not hear MLNM say in their conference call that they had discussions with the FDA prior to the phase II Velcade trial indicating that they may use the trial for approval.>>
NO. It come after PII, and based on strength of the generated PII data.
<<Most professional investors believe MLNMs Velcade strategy has significant risk.>>
Probably. They also think that Velcade will not make MLNM profitable. And, at this point, they are 50% right. But, they were 50% right with IDPH Rituxan in 98, and late prove to be 150% wrong.
Is MLNM desperate to move Velcade forward fast, generating risk? Many believe that this was a case. I do believe that MLNM is desperate, but it has nothing to do with early NDA. IF they have strong data, and I do believe that they do, why not ask for approval? Even IF FDA ask for more data, Velcade PIII will be completed before Thalidomide or Revimid PIII, and they do not lose anything. Only investors will lose confidence. However, investors are already without any confidence in MLNM, so who care?
V1, my view is that investors are complicating Velcade story from the convertible note side, not Velcade itself.
Miljenko |
