Replies to post #43918 on Biotech Values

[kcalt]

I think the FDA would be ridiculous to delay approval for additional data based on the panel's rec and the application going thru CBER. A delay on manufacturing is possible, but after all of the Cancer Vax workshop statements I think that VonE would be enraged to see the drug delayed after a postive panel vote.

I have been VERY long DNDN shares over the past 5 years and it has been a true lesson in biotech investing. I'm glad that I stayed the course despite most of the cynics (by cynics I mean every analyst and most everyone on this board!). I have been over my head w/ my long position and finally bought some hedges yesterday... Figures! Can't have it both ways. Enjoy your weekend everybody

KC

[palindromy]

I doubt it was compassion really.

The way the chair handled things(many small things adding up), and the specific responses from FDA on minute details, indicate to me that FDA was pushing for DNDN.

In fact, DNDN did quite a lot to screw it up -

1. They could never seem to get the projector working in time
2. They made the mistake of including and wrongly emphasising irrelevant stuff like Cox analysis and CD54 upregulation data. They had a tough time about both, better to have been honest and said - we dont know MOA and 9902B was underpowered!
3. They couldnt even get Eric Small at the panel. Talk about poor planning.
4. Elizabeth Smith looked like a deer caught in headlights most of the time up there and it was apparent that the panel only trusted Nicole Provost from all the DNDN staff.

OTOH, these are things FDA/Mule did -

1. Mule allowed the DNDN stat reviewer to respond out of turn to Maha Hussein who had just finished a 10 minute monologue on why this should not be approved. Damn, I was convinced at the end of her speech that Provenge was rubbish.
2. FDA stat reviewer stated repeatedly that survival was unlike multiple other end points that could be faked.
3. Mule reminded committee members a few times that they could approve and ensure that confirmatory trial was done(somebody else on the panel brought up Iressa as a good example since its approval gave patients options, advanced the industry and the drug was withdrawn when proven ineffective)
4. Most importantly, Mule picked up on the phrasing of the question and got FDA to clarify the intent.

While not a certainty, if FDA does not issue a full approval now, I would be as shocked as I am today.

[iwfal]

DNDN....what a stunner! How often do you find an advisory panel endorsing data from two failed pivotals? The question about efficacy was rephrased? Sounds like compassion was in play today, congratulations to the DNDN longs.

This was probably more about Therapeutic Index than compassion per se.

If it is low risk of harm in an immanently fatal disease the bar for proof of efficacy is (and should be IMO) lower. You can see that this was the issue by the penultimate question - which was about risk of harm.

Clark

[ThomasS]

DNDN: MsKatie, me thinks this will be good for all things Biotech.

[chantillylive]

Ms. K...

Stunned, astonished, amazed, aghast, staggered...

Oh, the answer ref your question on the two failed pivotals? the FDA doesn't need no stinkin pivotals. FDA flips and flops at will. I too am stunned by their decision.

Still long PPHM? I am.

cl.