BCX4430 has even been discussed in the Chemical and Engineering News (American Chemical Society) article about Ebola.
Like a lead balloon.
"The FDA assigned the NDA a standard review time, resulting in a PDUFA action date
of December 23, 2014
BioCryst and its peramivir Drug Product manufacturer are working with the FDA to
resolve outstanding issues and meet the requirements for approval of peramivir
BioCryst intends to make peramivir available in the U.S. "
If this doesn't happen folks -- "and away goes (credibility) down the drain -- roto router"
And throw in the mix analyst's myopic reactions to the HAE drug possibilities for Biocryst. Cinryze costs $2340 per single use vial. Pay attention Wall Street!!!!
And the negative reaction to it continues. The street loves to hear CEO's throw up their hands and say it's out of my hands!
See streetinsider for latest BofA downgrade with a price target of $8. Based on a "survey" of 20 EU docs, their patients prefer 2x weekly infusions (who prefers twice weekly infusions over pills?) than the pill regimen, while US docs prefer pills. I guess BofA discounts the intense effort underway at Biocryst to bring the pill count down; not to mention their support for DYAX. In the meantime, streetinsider has 12 buys, 1 hold, and 1 sell, with the rating trend going up.
Relax mdad. Take a deep breath. The new strain didn't start being prevalent until Sept; way too late to formulate vaccine. In most years, any flu vaccine is only 50 to 70% effective. That's just the state of vaccine science right now.
And Merrill supports a competing drug. So much for sell side analyst separation from the brokerage side.
And, I'm so glad Merrill asked doctors about their administration preference. I suspect they will prefer 2 visits a week to their office, instead of giving scripts for pills to their patients. Did Merrill ask patients what THEY prefer???
They don't do press releases, remember?
"But Me of big-time Babu faith."
Calm down David.
I am just not so sure FDA is really in tune with what HHS is trying to do; even if FDA is under HHS. They haven't bent over backwards to get P on track; if they were P would be approved by now.
Left2 - thanks for pointing out this post. I thought Peramivir was being hospital tested vs Tamiflu. But if the latter doesn't have much of an effect, how come P didn't shine in the hospital trials? What is being missed in testing these drugs? If P isn't approved by the FDA, then FDA should revoke Tamiflu's license. It has never really been proven to work. Such a conundrum!
Quote from Spokane paper, Spokesman-Review, from last year - "The FDA action (warning letter), however, does halt Hollister-Stier's production of substances being developed for clinical trials before they can receive final federal approval. Such substances are referred to as new drug applications, or NDA contracts."
"HS can't resume its NDA contracts until the FDA lifts the sanction. What's more, the FDA noted that 'other federal agencies may take this warning letter into account when considering the award of contracts'".
In my limited view, given the amount of time that the warning letter has had to be lifted, this is too close to the PDUFA date to be taking chances. HS has had over a year to correct this. I would watch the situation very carefully.
Yes me2, it may be expected. I've been at this a long time. And I know this about stocks - it doesn't matter what the street has already factored in; even repeated bad news gets a stock pps pummeled. Punish first, and ask questions later is the reality. That's why my advice to anyone reading this is watch the situation very carefully.
One more line from the Spokesman-Review article -
"HollisterStier has halted manufacturing the specific drug that was cited for irregularities during the FDA investigation, Jordan (HS spokesperson) noted. The company has a policy of not divulging the names of clients or the drugs they ask HS to make. Jordan added that the drug in question is not a vaccine."
Pretty ugly situation!
With Bellicum and Juno stealing the show, forget Biocryst for now.