Question for the board

[tigercapital]

This question is primarily to satisfy my own intellectual curiosity more than anything. The presentation given at the APASL Conference last month indicates "No laboratory signs of end organ toxicity" were observed. I'm not trying to debate the academic point here but is the implication here that there have been zero drug-related AEs to date? That statement combined with "modest, random occurrence of abnormal laboratory results" in characterizing the AEs had me thinking about whether this is in fact the case or not. I'm completely on board with the safety profile of DPCs but if this is indeed the implication that makes "well tolerated" seem like quite the understatement.

[mudbug021]

It has been my opinion ARWR management wording is the direct result of Oct 8, 2014. I would almost bet my house their lawyers advised them to error on the side of caution and not make anymore bold statements. Especially with having to deal with lawsuits pending. 

But since DPC inception (2007) there has been little to no AE and absolutely no SAE in that time span. Personally, I have no problem saying that is an astounding success rate. However, I think CA said in the last meeting he does expect some kind of  AE or SAE because it is the nature of the business. I will have to go back and verify that. In essence CA is using caution to prevent panic at a later date.  

If you are bored here is some lite reading on more detailed information about reporting AE/SAE

[tmak]

from dig's talk with ir:


Question: 2) regarding recently reported reoccurring AE (headache and upper repertory infection.) I understand headache but, upper repertory infection? Can that be related? During the annual share holder meeting Chris Anzalone mentioned we should expect to see SAE’s in phase 2.


Answer: I got the impression they were going to report AE’s as they encounter them. Maybe everyone is completely aware of how this works but, Every AE is reported during the entire test period so if a patient gets a headache or upper repertory infection during the test period it gets reported. They will be dosing nearly 300 patients for the better part of a year. During the entire year if someone gets a headache or …… it will be reported, so they are expecting AE’s and SAE’s. That does not mean they expect it to be drug related.