CC..I'm glad I opted for going to the beach..nothing earth shattering in the CC..Nance mentioned the short sellers raiding the newswires..and they addressed some of the blogger's/Feuerstein's criticism without mentioning names(so to speak)..ie..they stressed that the p53 biomarker data from P2 tumors that they released last Q was obtained in a blinded fashion..the P3 statistical plan using the biomarkers(which includes clinicals like response)was agreed upon with the FDA and they made an "IND amendment" versus getting an SPA..which they said would have taken longer to get the SPA than the former..this was a sticking point for the bloggers as indeed, in prior years, their 10Q's did indicate they had an SPA....I'm personally glad they didn't have one because it's much harder/almost impossible to amend an SPA..one of it's disadvantages..
They stressed strongly(Nance, Sobol, Talbott)that yes, the BLA will be filed by EOY..
They did talk about "adaptive clinical trial" where essentially, P1 and P2 data is scoured to find out as much as possible about the molecule(dosage, route, biomarkers, target population) when discussing all their work re: Advexin, Mda7 and the rest of the portfolio.....and this imho, is what the bloggers due diligence failed..since it's relatively new and is part of the Critical Path initiative(Wyeth, MD Anderson are 2 currently in the early phases of using it)...from what I'm reading this week, the P1/P2 phase necessarily takes longer but if done right, reduces P3 failure..when the bloggers made fun of Nance for in the past saying: "P1-P3's will be blurred," he was speaking using the model of this 'adaptive mode."...this link, on the bottom of page 3 says this verbatim pharmexec.com
For sure, he should have been explicit about this in the past.
They're designing a Mda7/Avastin which will be adaptive..
Obviously, it's up to INGN to meet guidance for their BLA submission by EOY since nobody on the call cared about the rest of the pipe until they do this..
Interestingly, someone from a cancer advocacy organization asked them about Gendicine and whether the FDA would use Sibiono's data and if INGN would work with them..Nance essentially said no to both.. |
