Dynavax Technologies Corp (DVAX)

[MrGuru]

The FDA has to balance the "public health" aspect of any drug. That, simply put is risk-benefit. The drug is superior, no question about it. The question is: is it riskier than the current SOC ?. The data gathered did not, and cannot, answer that question as was not designed to qualify MACEs.

In the FDA own words the number was small and, in DVAX words "Framingham Risk Score model for coronary heart disease event prediction. Accounting for risk factors in the population-based risk estimation models increased the expected number of events over the age-, sex-, and race-adjusted estimates. The number of observed events was similar to or lower than predicted in each trial and in HBV-16 and HBV-23 combined".

The issue is that in the Engerix-B arm the incidence was much lower.

The AdComm has two venues: request further tests focusing in the Cardio safety (CRL with no approval) or, approve with Post-Marketing Surveillance Plan (which DVAX suggested on their proposal).

I firmly believe that the latter rather than the former will be the outcome as, in reading in NARRATIVES OF POTENTIAL MYOCARDIAL INFARCTIONS, most of the events occurred to people that were already sick. For example: "A 62-year-old white man with a relevant medical history of coronary artery disease with an old lateral myocardial infarction (MI), dyslipidemia, multiple prior coronary stents, and obesity experienced an ST elevation myocardial infarction 319 days after the second HEPLISAV-B injection. " or "A 69-year-old white woman with a relevant medical history of obesity and dyslipidemia experienced a non-ST elevation myocardial infarction 208 days after the second HEPLISAVB injection. " or "A 46-year-old white man with a relevant medical history of sleep apnea, hyperlipidemia, hypertension, and obesity experienced an acute MI 175 days after the second HEPLISAV-B injection. " or "A 64-year-old white woman with a relevant medical history of type 2 diabetes mellitus, dyslipidemia, hypertension, heart palpitations, and sleep apnea experienced an event of coronary artery occlusion 14 days after the first HEPLISAV-B injection". I am just copying the FIRST 4 narratives (not cherry picking here "

One cannot blame DVAX for recruiting subjects with prior medical history, and, bedsides, one cannot forget that there was a, difficult to explain, unbalance with the other arm.

I am optimistic of the outcome and, obviously putting my money where my mouth is. Hopefully the AdComm and FDA will give DVAX the opportunity to prove that that Heplisav-B is not causing any MACE's and the number of events (as the study DVAX made suggests) are normal and low.