Replies to post #31136 on Biotech Values

[iwfal]

The reason it’s taking so long to get manufacturing ready is that DNDN knows there is no urgency; there is no urgency because (behind closed doors) DNDN does not believe that the current data package is sufficient for approval.

Your scenario doesn't make a lot more sense ... so they go to all the trouble and expense of setting up manufacturing and filing the BLA for ... ? And they drag out the BLA for ... ? The process of filing isn't going to convince anyone of anything, so what is to gain?

BTW - David has, without doubt, 'turned' on companies that were clearly incompetent. So your swipe was OTT.

[AlpineBV_Miller]

You didn't actually answer my questions, did you?

And was this really necessary?

It’s really that simple, IMO, but simplicity probably doesn’t sell newsletters.

[walldiver]

<<It’s really that simple, IMO, but simplicity probably doesn’t sell newsletters.>>

Wow. I bet you felt real good after letting that one go. Especially after you were deliberately provoked by the vicious personal attack on you quoted below:

"DNDN – If you know your BLA is rate-limited by a CMC section that won't be ready until Q4, why bother rushing the clinical section? What strategic or other value do you get by submitting the clinical section early given the FDA is already overwhelmed with filings?"

Dew--I too was shocked by the ferocity of this personal attack. I wish he would tone it down in these discussions.