Dynavax Technologies Corp (NASDAQ:DVAX)

Heplisav will be approved last quarter 2012 and their pipleine is strong

I recently did well on a green thumb on Dynavax, with the justification I provided here: http://caps.fool.com/Pitch/DVAX/5983252/dynavax-rose-as-high-as-316-in.aspx

I think the momentum has run out for Dynavax, and there's a good chance the share price will drop substantially between now and when any regulatory decisions are made regarding Heplisav.

1. The Heplisav ship has been listing heavily ever since the FDA shot down the vaccine for general use, supposedly due to a single instance of autoimmune disease in a recipient. Merck dumped the partnership. The company is now seeking approval of Heplisav in a relatively small subset of the general population (over 40 and chronic kidney disease).

2. There were three serious autoimmune events reported in the follow-up phase III trial.

3. The Heplisav BLA submission was postponed from Q4 2011 to Q1 2012 without much explanation.

4. The company has taken advantage of the stock run-up by raising money heavily through dilutive financing. Prudent, yes. Optimistic, no. The cash cushion may make Dynavax another green thumb stock if the share price gets beaten up badly on Heplisav rejection or sell-off after approval.

Lead product Heplisav should be approved as efficacy, safety and manufacturing consistency all appear to have been achieved. FDA submition within 3 months and significant advantages over current market leader engerixB. This product alone justifies three times the current market cap. Add to that the pipeline, most significanlty the Universal flu vaccine, based on the same technology that created Heplisav.

biot

good pipeline in the works and a good technical chart cupping around it's 200 day M.A.

Very good sponsorship by institutional funds. Employees enjoy partnership in ownership. They are burning rubber.
Would not like to be short Dvax.
Fuzzy114

MB7 Z3

hepislav is a hit and will be approved.

They keep attracting money.

If current testing is successful.

These guys may have something on their hands possibly a new Hepatitis vaccines that is going into the 3rd round of FDA trials. Typically a good sign.

dvax

Expect the huge gap to get filled over the next few days and a slow rise back to 6 over the next couple of months.

another hope for quick accuracy points.

Small biotech has recently released promising late stage trial results for its HEPLSAV hepatitus B vaccine drug, as well as encouraging earlier stage results for its TLR9 agonist in cancer indications. The stock took a large hit Jan. 8th when its TOLAMBA allergy drug failed to show therapeutic benefit based on interim analysis, that appears to present a buying opportunity, particularly since the reason for the failure appears to be the lack of clinically significant disease in the study population. Cash of $1.50/share & no debt and the recent filing of a $100M shelf registration suggests the company is well-positioned to leverage its recent progress into further positive developments. the stock appears to offer a reasonable risk/reward after the recent sell-off.

this company has the best TLR-9 technology and excellent recent clinical trial results on both its allergy program and hepatitis B vaccine program, both of which address large markets.

This Co. has a cure for hayfever. There's a very large demand for such a product. Buckle up your seat belts for a nice ride up.

I was evaluating their research data regarding influenza vaccines and missed the doubling in stock price, but this may just be the start. Their patented methods widen the range of protection from immunizations. This could be HUGE if it means protection from future viral epidemics.

This sock is moving up, and its on news that has nothing to do with the alergy break thu, that will propel this company to the outer limits. All of my family has an alergy problem and are waiting for this pill or shot.