Check out Reuters story today RE: GSK (and likely Dr.Daum's corrupted negative vote on new vaccine adjuvants.)
(Reuters) - Growing evidence of a link between GlaxoSmithKline Plc's pandemic flu vaccine and an increase in narcolepsy cases among children who received it in Europe, is giving pause to health regulators weighing approval of a similar vaccine in the United States.
Data published recently in the British Medical Journal found that children in England who received GSK's Pandemrix vaccine during the 2009-10 H1N1 swine flu pandemic had a 14-fold heightened risk of developing narcolepsy, a chronic and potentially debilitating sleep disorder that can cause hallucinations, daytime sleepiness and cataplexy, a form of muscle weakness precipitated by strong emotion.
Authors of the study - whose results echo those of similar studies in Sweden, Finland and Ireland - said the data had implications for the approval and use of future vaccines that, like Pandemrix, contain AS03, a new adjuvant, or booster, that turbo-charges the body's immune response to the vaccine...
by the way this stock is heavily menipulated by hedgies, adam devilestyn and cramer the homer,,they will do the same again before approval,,so buy as cheap as possible when they take it down. be prepared!!.
lets say the wall street bstrds come up with some neg articles before the next run up, as thats what they usually do with the help of adam devilestyn. i will wait patiently for a sweet entry, i know they will beat it down for their own entry. so i am keepig an eye on for a sweet entry.
Holly #$%$ this so much bigger if true than anything else. This has now direct ties and results to GSK as being a source of narcolepsy in children. Maybe when Dr.Daum was looking at DVAX his total toughts were on GSK and how it caused narcolepsy. WILL THE FDA OR better yet FBI follow the money trail. Lets hope so. ALSO DVAX does not use this adjunvant and should be clear for approval. Now we are 100 open for approval from 40-70 with a quick backdoor to yougher age once gsk buys us out for $22.40/share.
Sentiment: Strong Buy
Exactly right DrJ. Now we know the backstory to the corruption of Dr. Robert Daum by GSK. Basically, GSK saying "since our novel vaccine adjuvant doesn't work, we won't let DVAX's novel adjuvant reach the public". Pretty awful and cowardly of GSK.
"Lets hope so. ALSO DVAX does not use this adjunvant and should be clear for approval."
You're missing the point. You are correct that DVAX's adjuvant is totally dissimialr to AS03. The only thing they have in common is that they are novel adjuvants and induce a higher level of immune response. The reported narcolepsy events associated with AS03 have occurred in about 1 per 30,000 individuals treated. You cannot superimpose the AS03 experience on Heplisav, but you can look at how the AS03 experience should affect the approval process for any novel adjuvant. Heplisav's safety data base is only about 4,000 treated patients, far too small to detect a safety signal that may only manifest itself in 1/30,000. So FDA and EMA have to look at this and take one of two tracks, either require a safety database large enough to detect a rare but real SAE or restrict the use to a population in which the benefit profile clearly outweighs even a theoretical safety concern.
I do not believe DVAX uses the GSK adjuvant mentioned above.
That being said, I guess the point of the Reuters article was to highlight why GSK (via Daum) corrupted the AdComm panel - because GSK couldn't get their novel adjuvant to work, they had Daum transfer this fear to the completely unrelated novel DVAX adjuvant. Note that the problematic GSK adjuvant was used in a pediatric setting - the exact same idiotic and hypothetical rationale Daum partially used to justify a no vote for Heplisav safety (even though Heplisav was targeted for 18-70 years).
To be fair, a brilliantly corrupt strategy to get Daum on board to plant the seed of fear for DVAX that was experienced by GSK for their failed adjuvant. Daum can honesty say that he was worried about the Heplisav adjuvant in children (even though that was not the age groups being sought by DVAX nor even remotely related to the DVAX adjuvant).