When panel members admit that they don't have the expertise to render judgement on WL, they almost always err on the side of caution. I got the feeling that the panel did NOT have the extended Aussie data going out 5-7 years. The FDA does and I believe is anxious to approve VBLOC and see 24, 30, 36 month data in the future. In the ongoing dialogue with the FDA, Enteromedics is probably on the verge of submitting 24 month data as it will almost certainly show backsliding of the sham control group.
By approving VBLOC, the FDA gets brownie points for approving another tool against obesity, hypertension, diabetes and some cancers: a no brainer.
After buying 1000 shares AH @ 1.73, I waited for a sharp pullback which never came. I thought about waiting to buy more in Wednesday's pre-market or even waiting for the market open as sometimes there is a concerted short effort: however, I reluctantly went all in at 1.85(not expecting a fill) but got 13,531 shares out of 15,300 filled. My avg cost on 18,731 shares is 1.79, so my downside is limited.
What heartened me is that the FDA was very accommodating to VBLOC. Our dear blogger Ted Kyle hit the nail on the head about the mixed 4-5 and 6-2-1 votes:
"Interesting that multiple panel members have commented that they don't have the expertise to render judgement on WL "
Pete: You promised to leave I gave you the proof FDA approved a drug despite unanimous negative ADCOM. I guess you lied ...again!
peteharmisan: YOU HAVE TO LEAVE THE BOARD NOW as I have the proof. AN FDA panel voted unanimously against approving Zohydro, but the FDA ignored them and approved the powerful opioid.
Love_love_virgo: I'm not getting a good feeling about YOU! Your ID is only five days old while mine has been the same for many years.
Unfortunately, the letters are a formality that rarely sway an FDA panel.
Ade: Actually quite a few ADCOM panels render negative votes, even for some of the largest drug companies. The bureaucratic system likes to waste time and money. I experienced this first hand in the late 1960s: I scored high in the air traffic controller exam and received a letter of appointment and stated salary. I just had to pass an interview with a veteran supervisor(I did); however, they saved the extensive physical exam FOR LAST. I passed fine except my partial colorblindness disqualified me! WHY THE HELL DIDN"T THEY LIST THAT AS A DISQUALIFIER UPFRONT?
Correct me if I'm wrong: roster lists 9 voting members, plus panel chair(I believe only votes to break a tie). The consumer rep, patient rep, industry rep normally can't vote and I'm not sure about the designated federal officer.
Ade: The FDA poster roster shows 9 voting members. It does not state whether the following on the panel have a vote: panel chair, designated federal officer, industry representative, patient representative, consumer representative.
EnteroMedics also made a mixed case with data on co-morbidities. For patients with the Maestro System at 12 months, mean HDL cholesterol ("good cholesterol") increased more than for the sham group; LDL cholesterol ("bad cholesterol") fell more than for control; and triglycerides fell less than for control.
The system met the safety endpoint of less than 15% of treatment subjects requiring implant or revision procedures at 12 months.
The panel is also considering whether it should require a five-year, post-approval effectiveness study. If it votes in favor of the device, given the mixed data, this seems a likely requirement.
(This is a free newsletter I get everyday in my mailbox)
An implantable device to treat morbid obesity with vagal nerve blocking therapy will be considered by the FDA's Gastroenterology-Urology Devices panel on June 17. Its chances going into the meeting don't look great: The panel documents point out that it didn't meet either of its primary efficacy endpoints and the panel date was already delayed once in March. Still, while the 12-month data aren't good, at 18 months the device looks a bit more promising.
The very first question from the panel in newly release documents addresses the lack of efficacy data. The primary effectiveness endpoint was to demonstrate at least a 10% improvement over control in excess weight lost as measured by body mass index after 12 months.
The Maestro System from EnteroMedics, which includes an implantable device that intermittently blocks inter-abdominal vagus nerve signaling, showed that 24.4% of excess weight was lost, while the control group shed 15.9% of excess weight. The difference between the two groups was 8.5%, not the 10% improvement that's the standard for demonstrating efficaciousness in weight loss.
In addition, the secondary co-primary effectiveness endpoint also was not met. It had two parts: that at least 55% of subjects lost at least 20% of their excess weight and that at least 45% of subjects lost at least 25% of their excess weight. Of the data for subjects using the Maestro System, 52.5% of the subjects lost at least 20% of their excess weight, while 38.3% lost at least 25% of their excess weight.
Although neither of the effectiveness endpoints were met at 12 months, the company provided 18-month results that are better. At this time point, patients on vagal nerve therapy had lost 25.2% of their excess weigh while the sham control group lost 11.7%--that's a difference of 13.5%, which exceeds the 10% threshold.
EnteroMedics also made a mixed case with data on co-morbidities. For patients with the Maestro System at 1
I just added 1000 shares @ 1.4799; own 4200 total. Will only buy more today if there is a further dip. Most of my cash is in reserve to trade after ADCOM vote.
jcleage: I'm not mad at oozhe. His seemingly "factual" posts have an orchestrated feel. I would just like to know his ownership history, if any, of ETRM. As for me, I live in Los Angeles and for the last six years have offered to take to dinner to any poster who passes through L A. No takers yet...I guess robots don't eat.
oozhe: You mind me of the Whole Foods CEO some years ago who secretly posted hundreds of seemingly erudite negative Yahoo messages on the Wild Oats board ...and then bought out Wild Oats!
Can you please tell me what your true motivation is on this board? Have you ever owned ETRM stock and did you make money or lose money? I like spirited debate but your aggressive one-sided arguments seem to have a hidden motive.