Also, the company would never state the CFO was fired. This opens them to litigation as the original PR stated, in part "....today announced the departure of Dennis Turpin, the Company's former Senior Vice President, Chief Financial Officer..." Corporate emails don't say, "Investing in drug-discovery stocks is risky, which I'm sure you have figured out". or "You should check your facts." That is most unprofessional.
As I said in another post, I feel for the people awaiting their next injection or anticipating the first. This is one case where, clearly, the benefit outweighs the risk. DO said the conversation with the FDA went well. The requested information was sent. Now, it's wait and see.
All the information that the FDA requested was sent so I hope it's not too much longer. I think the JUNO (and more serious, IMO) hold was about three weeks. We're in week two. DO sounded pretty sure it would be resolved expeditiously but it is the US government, the world's most effective and efficient body.
They may be making protocol adjustments to the trial. Perhaps limiting or excluding items such as implants or prosthetics. What impressed me on the CC were Drs. Mauro and Petit being emphatic the the Listeria was not related to the patients death. No "maybe". not "possibly" but "not related". It all comes down to the FDA but they did their homework, consulted the CDC, other experts and existing literature. I believe, though, when this is done the SPA will go through.
When did they ever say an autopsy was to be done? The investigator already stated the death was due to metastatic cervical cancer. Nothing on the CC alluded to an autopsy.
The consulted with the CDC and Listeria experts (if I recall correctly). They did their best to get their ducks in a row.
You are half correct. The trial was stopped (IMO) due two two items. One, why was there Listeria still in the patient and, two, did it have anything to do with the cause of death. Both items were addressed in the CC in detail.
Listening to the CC again, I totally agree. Dr. Mauro was adamant that the vaccine played NO role in the patient's death.
I read he passed away on February 17, 2015. He had been on the IMUC trial but dropped out when the cancer recurred. He put up a brave fight. If you Google his name, you will see the obit.
Perhaps an update with the canine numbers?
"A total of 13 elite funds reported holding stakes worth $205.57 million (32.2% of the float) as of June 30, up from 12 funds and $123.68 million respectively a quarter earlier. Phill Gross and Robert Atchinson‘s Adage Capital Management increased its position by 10% to 5.64 million shares while Kevin Kotler’s Broadfin Capital raised its stake by 80% to 1.45 million shares. Samuel Isaly’s Orbimed Advisors upped its position by 76% to 755,100 shares. 25.1% of the float is short."