This company is well run, just suffers from uncontrollable political and economic forces that produces challenges...I'm a long holder. Things are steadily getting brighter for PEIX from here.
Thank you Daddy! My thoughts exactly...how can "careful" compute "8x better" when Serepta themselves have been having trouble making their own quantitative determinations...and yes...SAFETY. Do we know Wave Life Sciences safety yet?? Don't think so
I'm a long SRPT holder and want a positive outcome for the shareholders--me. But FDA was not the sloppy ones entirely...
As crews fueled an Alaska Airlines 737 for the first commercial flight using biofuel derived from corn, it was a historic moment felt strongly by third-generation farmer David Kolsrud.
"I didn't think I'd ever see the day when a product I raised would be on an airplane in Seattle," Kolsrud said.
The protein in the corn he grows in South Dakota feeds animals and the carbohydrates now fuel planes, after a company called Gevo created an alcohol-to-jet fuel.
On Tuesday, Alaska ran two demonstration flights from Sea-Tac Airport, one to San Francisco and another to Washington, D.C., with a 20 percent biofuel mix.
Gevo CEO Pat Gruber went through a six-year approval process.
"There's no safety issue here. I'm going on the plane, by the way," Gruber said.
Alaska demonstrated a different type of biofuel in 2011, which worked fine but was expensive.
The airline says for the two-flight demonstration, it is paying six times the price of regular fuel.
Costs are expected to drop as production ramps up.
"We should be in the realm of cost competitive with fossil based resources," Gruber said.
How long will that take? "A couple three years I think," Gruber said.
Both Alaska and Sea-Tac say they want to reduce greenhouse gas emissions.
The airport is studying a system to deliver biofuel to planes.
"We intend to show our sincere desire for a large quantity of biofuels to be produced so that we can start using them not just on demonstration flights but on all of our flights," said Joseph Sprague, of Alaska Airlines.
Alaska plans to do another demonstration this fall using biofuels from forest products.
It hopes by 2020, it will be able to regularly fuel planes with biofuels at least at one of its airports
It isn't about PEIX but it IS about ethanol use demonstration!!!
Exactly what I was thinking...who would buy if there wasn't some +++ feeling here?
..then try to strike up some convo with someone who has heard scuttlebutt inside about the confirmatory WB results
I predict FDA supports 'compassionate use' pending data supporting accelerated approval from the larger trial. I don't know the current status of the larger trial--are they fully enrolled? Anyone know the timeline in which we can hope to hear results? I seem to remember 24 weeks doesn't show much difference...maybe need to wait for 48 weeks
By Ben Levisohn
Yesterday, shares of Sarepta Therapeutics (SRPT) lost more than a quarter of its value after the FDA issued “compassionate-use” guidelines that were widely seen as a precursor to a rejection of Sarepta’s Duchenne muscular dystrophy drug. Baird’s Brian Skorney and Neena Bitritto-Garg call the reaction “fundamentally wrong”:
FDA updates expanded access guidelines. As we await the FDA’s decision on accelerated approval of eteplirsen, the agency released an announcement on new guidance and a streamlined process for the “compassionate use” expanded access program and charging for an investigational drug under the program. Although this guidance has been in the works for months, maybe years, we do find last week’s PDUFA delay to be curious timing in light of this issuance. We’ve continuously said that this could be a good compromise for all involved. The initial reaction to the stock is pretty negative. We think that is fundamentally wrong and here’s why…
Defitelio – the model for Sarepta to follow. Gentium was a publicly traded company in a similar situation several years back with a drug called defibrotide. A small data set in a highly fatal disease that primarily effects children led to a situation where doctors refused to consider placebo but the FDA/EMA could not approve based on the available data. FDA approved expanded access for the drug under a treatment IND with cost recovery and EMA took a similar approach. Gentium was cash flow positive for years (albeit marginally so) before getting acquired for $1B by Jazz Pharmaceuticals (JAZZ). Earlier this year, FDA approved defibrotide based on data generated under expanded access.
Sarepta needs to get to an exon 45/53 readout. We think this is the definitive study that will address whether or not PMO-mediated exon skipping leads to a beneficial clinical outcome. If it does, we believe eteplirsen gets converted to a commercially approved drug within a year of readout along with the company’s exon 45