Dynavax Technologies Corporation Message Board
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buy out on the horizon
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to cover your loss. good news on the way
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to cover your loss. Good news coming soon
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show me money
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'm buying
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Earning has GOT nothing to do with DVAX; THEY ARE NOT REVENUE GENERATING COMPANY
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Long don;t care
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DVAX $2.49 break would set it off 50dma
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The ubiquitous CRL in biotech has made its way into the news headlines again. But is the Complete Response Letter a game-changing hurdle for a biotech, or is it par for the course these days?
It turns out that almost half of NDA/BLA filings get rejected by the FDA on the 1st round. However, most companies resubmit their application, and by the 2nd review 75% of drugs gain FDA approval. After heading for a 3rd attempt, the cumulative percentage climbs to 83%. After that there is little data to support that subsequent submissions materially impact the probability of approval. -
The ubiquitous CRL in biotech has made its way into the news headlines again. But is the Complete Response Letter a game-changing hurdle for a biotech, or is it par for the course these days?
It turns out that almost half of NDA/BLA filings get rejected by the FDA on the 1st round. However, most companies resubmit their application, and by the 2nd review 75% of drugs gain FDA approval. After heading for a 3rd attempt, the cumulative percentage climbs to 83%. After that there is little data to support that subsequent submissions materially impact the probability of approval. -
It turns out that almost half of NDA/BLA filings get rejected by the FDA on the 1st round. However, most companies resubmit their application, and by the 2nd review 75% of drugs gain FDA approval. After heading for a 3rd attempt, the cumulative percentage climbs to 83%. After that there is little data to support that subsequent submissions materially impact the probability of approval.
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no worry about fin- Cash in hand only $125 million. Other 2 products they are working on to be financed by GSK and AZN
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One way or the other, DVAX at current price is a superb buy. FDA will approve its vaccine's restrictive use for population from 40 to 70, as the co originally applied for. S/P will go up upon the news. In time it will be approved for those under 40, if it is not taken over by a big pharma. Such setbacks provide the opportunities to add to position for the ultimate gain within a year at most.
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with the recent setback in the FDA and the drop in the stock's price, the company may become an even more inviting target for a takeover. Recall a similar situation with Medarex some years ago, when that company's trial for ipilimumab ('ipi') for the treatment of metastatic melanoma yielded marginally positive results. The stock was languishing around $6-8 a share when Bristol-Myers Squibb (BMY) surprised the Street and bought the company for $16 per share. The drug is today marketed as Yervoy. Surprises do happen!
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From a technical perspective, DVAX ripped higher here off oversold territory with above-average volume. This stock recently gapped down from around $3 to $1.87 with heavy downside volume. Shares of DVAX went on hit its recent low of $1.74 and the stock entered oversold territory, since its relative strength index reading went below 30. That said, shares of DVAX have now started to rebound off that $1.74 and shares are quickly approaching a major breakout trade. That trade will hit if DVAX manages to take out some near-term overhead resistance at $2.13 to $2.14 with high volume.
Traders should now look for long-biased trades in DVAX as long as it’s trending above Tuesday’s low of $1.91, and then once it sustains a move or close above those breakout levels with volume that hits near or above 3.26 million shares. If that breakout hits soon, then DVAX will set up to re-fill some of its previous gap down zone from late February that started near $3. Some possible upside targets if DVAX gets into that gap with volume are $2.70 to its 50-day moving average at $2.80 -
I work in a financial institution. We don't know who SHEF or BEEFF is. We as MM along with hedgies control the market. Sheff/Beff has got nothing to do here.
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who the hell sheff is anyway?
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What would be fair market value of APPA even if this get approved for one product and no partner .
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Market cap toooooo high