Biotech Values

[mcbio]

IDIX - sold position

IDIX is up substantially since I wrote this. Either things may not as dire or this is a run up to AASLD. No official letter yet.

I decided to take all of my IDIX chips off the table for the time being because I had a fairly nice gain after dollar cost averaging around the $2 level coupled with all of the uncertainty surrounding J.P.'s departure/forced resignation, the clinical hold on 184/320, etc. I listened to IDIX's presentation on 10/30 (believe there was an additional one a few days after that I didn't listen to) and I believe it was the CMO that just didn't display a lot of confidence to me regarding a timely lifting of the clinical hold on 184/320. A few points from that presentation:

1. There was an indication that IDIX had received a letter from the FDA, though I guess the details of the letter won't be disclosed.

2. Regarding the timing of the lifting of the hold, he indicated that IDIX can't predict if they can fix the issues quickly or if it will take time to get the hold lifted. It was noted that IDIX would be submitting all final locked data on 184 and 320 to the FDA by the end of the year and the timing of any lifting of the hold on 184 and 320 will depend on the "next round of questions" from the FDA.

3. IDIX apparently hasn't conducted any of the pre-clinical DDI tox studies for 184/320 that were previously alluded to. This kind of caught me off guard as I assumed they would have already started these. I'm not sure if they need to wait for those "next round of questions" from the FDA to get specific guidance on what additional pre-clinical tests need to be performed.

Separately, I think it's quite likely given the hold on 184 that this pushes VRUS into the lead for being the first to get a 2nd gen HCV nuke partnered. I think it's possible we could see weakness in IDIX shares if VRUS does indeed find a partner first. But, I also think there is plenty of room for another 2nd gen HCV nuke and I do believe that IDIX will eventually partner 184. But, at a minimum, I need to see the drug off of hold before I consider going long again.