Based on what we know, Dynavax is working with the FDA to determine guidelines for their next safety study. There is no other information available. Obviously there are going to be additional costs, but as an investment they are well worth it as Heplisav works and will be out in the market someday helping people. The stock price is going lower because no one expected this type of drop, as most of what we learned June 10th was already public knowledge. As it happens, most investors, hedge funds included, are leveraged and use margins with only lesser amounts of cash as collateral. When a stock falls dramatically, use Apple as an example, people are forced out of positions as no one planned on a 10%-20%+ drop. This drives the stock lower, and lower, and lower as more investors have to deal with margin calls. There is also the possibility that computer algos are running through the books knowing where investors have their stop limits placed, and slowly but surely the algos will get there to scoop up shares that people could not afford to buy in the first place....borrowing money to buy stocks will get you in trouble - not even taking into account the 7% or so interest many houses charge.
The lesson here is: don't panic and don't invest using margins. The stock market is the biggest casino going, and you will lose your money if you are not able to withstand these types of situations.
Another lesson will be that a good vaccine will ultimately find its way to the market. In this case, there was obviously a bit of confusion as to what the FDA was expecting from Dynavax when their original safety study began. That will be fixed and Heplisav and Dynavax will reward patient investors.
US FDA vote was 5 approved 8 denied 1 undecided for Indication Age 18-70, and is still providing a path forward for continued interest. FDA members are indicating they want 8k to 10k patients whereas DVAX currently has results for 3.5k. DVAX will need to play it safe in this case and get data on 15k patients. FDA concerns appear to be with DVAX's novel adjuvant which can be rare or odd in the outcome. Proprietary protection with patent office until 2018 and can be extended or protected to 2023. It unlikely that it can be copied or stolen. In the meantime EU regulatory "120 Day" application review is expected to be determined by December 2013. I suppose the opportunity for EU approval will send this stock back up to $4-5 prior to December 2013. DVAX will pursue full age indication as opposed to limited age in the US based on Willam Blair's 33rd Annual Growth Stock Conference.
I own this stock and I'm long.
Sentiment: Strong Buy
Don't wait to buy only a few more months before this hits 5 pre (DEC'13) EU regulatory approval. New CEO used to sit on EU's Board. It's a no brainer on this one at current price of 1.13. Load up. Shorts will get squeezed giving up the needed upswing to $2 a share in 30days.
I agree with this. I'm thinking management may also be coming from the underpromise perspective given the recent turn of events and there could be a surprise or two for the positive..pure conjecture.. I'm quite surprised the market took the news so bad...given the CRL..where all of this was clearly a possibility.To me, if you can stomach the twists and turns you have a shot at some good gains..you can only play the odds based on your dd..mr market decides the rest.
Agreed. Good write up. The recent news really is not that much of a surprise. It has been known for months that DVAX may have to do a more expanded trial. About 6,000 individuals have been tried and looks like DVAX needs 4,000 more. EMEA may have good news and regardless however EMEA reacts will be steps forward. Ultimately, DVAX will do what is needed to bring this Hep B vaccine to global markets. Ups and downs are part of the process. Long run there will be profits. And should the stock fall too much and in particular by shorts that only encourages a buyout due to the low overall stock price and such buyouts always leaves shorts in the dust.
Sentiment: Strong Buy