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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: Henry Niman who wrote (15611)	2/22/1998 7:39:00 PM
From: WTDEC	Read Replies (1) \| Respond to of 32384

Good evening Henry and all LGNDers. It has been an amazingly quiet weekend on the LGND thread! Perhaps it is a case of group exhaustion from the hectic pace during the week. On the other hand, maybe everyone is resting up for an even busier week starting tomorrow!!! One area which I lack much understanding of and which is particularly timely with respect to LGND, is preparation of a NDA. I'm generally familiar with the FDA process, it's purpose and the huge volume of information a NDA entails. What I don't understand at all is the effort required to complete it, the range of expertise needed, the time it should take, how to judge management's performance in moving from P3 to NDA filing etc. While I'm sure the specifics in each case have an important bearing on answers, it would be helpful to better understand what goes on during the NDA process in general. Another way to state my concern is: What are the sorts of things which make a NDA 'easy and quick' versus another which one would expect to to be 'hard and take a long time to do'? Being somewhat cynical by nature, I sometimes think (but deep down I know it is not realistic) that an NDA should be prepared in draft during the late stages of the P3 with the 'blanks' filled in as soon as the P3 data analysis is complete so it could be filed immediately. Clearly, the sooner an NDA is filled (certis paribus) the sooner the drug will be available to help the sick and reward those who took the risk of backing the company developing the drug. On the other hand, a sloppy or hastily prepared NDA could result in a long delay if it is turned down because of that. As you can see, I'm really troubled by this matter and can use any help you or others may be able to offer. As to the current LGND NDA situation, I think it is of paramount importance that the NDA be perfect since it is our first and the first is the most visible and a key builder of the companies culture. I surmise that all is well in this regard. I also infer from various subjective inputs that the NDA is very close to submission. I look forward to any enlightening comments on the process of completing an NDA. Regards to all. wtd PS: Apologies for the length of this post....