I only have one negative re: Grey. The prior leadership was arguing for a narrow label. Grey agreed with FDA that the safety sample was too small and then tried to sell that agreement to us as a win. The stock promptly dropped 50%.
04/30/13 Dynavax Technologies Corporation today announced that the Company's board of directors has appointed Eddie Gray chief executive officer, effective May 1, 2013.
40 days later we had the meeting with the FDA
I would submit that Grey in no way could have swayed them in this matter. Under Dino the FDA had covered a indication in adults 18-70 years of age.
Now if the "Leadership was arguing" for a narrow Label I don't think that was ever in print ( Wink Wink )
Also there was no way you would get a narrowed label without another study anyway.
06/10/13 -- Dynavax Technologies Corporation today reported that it recently concluded a meeting with the U.S. Food and Drug Administration FDA regarding its Biologic License Application BLA for HEPLISAV, an investigational adult hepatitis B vaccine. The meeting followed recommendations expressed in November 2012 by the Vaccines and Related Biological Products Advisory Committee VRBPAC regarding the size of Dynavax's safety database. The meeting with FDA resulted in the following messages:
The safety database does indeed need additional subjects;
VRBPAC's strong endorsement of HEPLISAV's demonstrated immunogenicity was acknowledged;
Analyzing the benefit/risk of HEPLISAV's use in discrete patient populations did not fundamentally address the shortfall in the safety database. It was concluded that to do so would unnecessarily restrict the patient population that could benefit from HEPLISAV's approval;
So your post implies a negative tone for Grey
Courious , might you elaborate what your really trying to say?
Are you suggesting in any way he could have changed the course of what had transpired before he arrived.
Or that he could have fast tracked Hep-Lisa-V in any way?
What is your point here?
This from when Grey came onboard Aug 2, 2013
Try to imagine the situation old Grey's put himself in.
O the pressure to maintain ones reputation within the industry.
There is no way He took this on without believing in the" Science "
Going down as the Heplisav burglar would tarnish ones Stellar industry record.
But to get Heplisav approved and the " Science " Validated, Well that would be Quite the macaroni
Rock Star Status
If you lessened to the presentation, He said it " It's the Science " And that must have been the attraction for him.
You Think he did some DD before he took on this Job?
As shorts dig deeper and deeper that removed builds up for the longs.
Let them do the heavy lifting.
If this gets approved or as we head toward approval we reap the reward of their hard work
So that's your big revelation a crystal ball ?
So you have shorted based on another stocks path totally unrelated to the possibility of a approved Vac of this equity.
WOW .........WOW ...........WOO ...........2 Funny
No need to tap reserves the shorts will supply 100 M plus and we will have a product.
If all goes as planed
Good Luck on your trade