Replies to post #44982 on Biotech Values

[ronpopeil]

David,

I really enjoy your posts. They are both informative and educational. I'm confident we will receive fda approval. What do you think the chances are we receive full approval? Do you think we get it before the mid-May date? Also, why is there so much negativity on wall st given the overwhelming approval provenge received from the advisory board? Sure, there are always dissenters on that board but why is there is much attention being paid to these dissenters and very little on those who voted for provenge? Thanks!

[DewDiligence]

You like to use the accusation of personal attack to shield you from discussion of your motives. That’s understandable, albeit not especially noble.

You have IMO been intellectually dishonest in the discussion of a CU program by saying that a CU program is "a garbage solution" that would put DNDN in an “impossible situation” and preclude full enrollment of 9902b. DNDN’s own enrollment numbers say otherwise, however. In all likelihood, 9902b will be fully enrolled by the time the FDA makes its decision in the next few weeks.

[poorgradstudent]

>Let's say for a moment your assertion that DNDN can afford to do a CU program is correct.<

Just to set the stage for this discussion, I think it needs to be pointed out that the FDA allows cost recovery to the sponsor of compassionate use exemptions. Therefore I don't think it is reasonable to say that it is a cost issue. I get this feeling that many are working under the assumption that if Provenge is going to sell for $X when on the market that it will cost DNDN the same $X to treat every patient in a CU program. That is not the case.

Most sponsors running a CU program in trial form (osip did this with tarceva) offer qualifying patients the drug for free. Arguably one of the factors is that the company would rather not disclose true costs of the drug to a large community of patients. However, I don't think that any patient would begrduge DNDN recovering costs of Provenge used in a CU program.

And although enrollment can be negatively impacted in many cases, i think that reason is a red herring in this particular example. The enrollment in 02B has clearly picked up, and arguably it will be fully enrolled very soon. At the stage 02B is at, an enrollment delay is not a reasonable argument to nix the possibility of a CU program. All in all, the argument against a CU program isn't all that convincing imo, and is simply tugging at people's emotions.

With that said, I'm not sure the FDA should be in the business of mandating CU programs to sponsors. But that is a separate matter.