Consider that Arikace is direct delivery with a slower release, what does the %change in Pa sputum density show? Seriously (well not really)…can someone explain why the negative % change in Pa density in the Tobi arm is greater than Arikace and then why this goes below the Arikace negative % change by the third month? I can understand why Insmed did not touch on this, but why did nobody ask? I wonder what the longer term 110 study might show with respect to the Pa sputum density.
The Arikace liposomes penetrate the accumulation of sputum etc, so that from the word go the antibiotic effect is being spread over all of the bacteria in the accumulated gunk - whereas because Tobi doesn't penetrate, the bacteria on or close to the surface are initially exposed to a higher concentration of antibiotic.
After a few weeks Arikace has delivered a sufficiently high concentration of antibiotic so that the whole of the gunk is being exposed to a higher concentration of antibiotic than Tobi is capable of delivering.
nobody asked because nobody like you (or rehdvm) ever bothers to call in.
the "analysts" are plebs, and are "analysts" for dozens of companies (masters of none)
and why is the FEV1% way way down compared with Phase IIb results? which were faked? the phase IIb or the phase III ??
I actually called in and asked about a master file for the liposome one or two CCs ago. I guess you did not listen.
But it does not matter in a head-to-head study of Arikace and TOBI because both were used according to label copy instruction. Any difference in pharmacokinetics is irrelevant. INSM keep touting SID (single administration per day) use to save time and take advantage of the residual effect of the liposome amikacin. The primary endpoint was FEV1 and there was essentially no difference, even with the liposome delivery vehicle. Now it would be important for a three way statistical comparison of TOBI, Cayston and Arikace. That is mostly academic, but it might reveal some little subtlety about frequency of administration. But anyway, the big issue is whether there will be any attempt to use EMEA (Euro data) to try and influence the FDA. The trial on this side of the pond was going to be a comparison of the liposome and Arikace. The liposome by itself would presumable have little effect on sputum colonies. I kept telling everyone on this MB that at least two logs of killing power would be pivotal. Two longs is 100 bacteria. The knockdown for Arikace was just under two logs according to the charts. If they had achieved three logs kill, there would have been no doubt and Arikace would be expedited. Inhalational antibiotics are supposed to kill bacteria as a primary mechanism of action.
Ok michael- give it your best shot..Do you think the results sucked so much because the trial design was poor or too short or ?? "faked" ,Do you think the FDA will mandate a longer trial in the US? and this(long term trial) was the reason for Insmed declining to do a US trial? .(as mentioned Will Lewis dropped the filing in the US)
As far as the analysts,I have no doubt they were/are a willing party..
doughcm • May 22, 2013 5:42 AM
" Amazing how Bande and the numbnut Terry know so much more than these analysts."
I guarantee the analysts are in on it. ****Lazard**** - a former Iplex pumper that shorted the hell out of INSM 4 years ago is a interesting omen" terry_insm • May 15, 2013 4:14 PM