wallstreetbuyer: the downturn is over. If you are any kind of small biotech/medical device observer, you should know that surprise catalysts can happen at any time: additional CE mark from EMEA, a partner either in U S or ROW, an upgrade, or even an unsolicited buyout offer.
It appears to me that ETRM left some details out of the original proxy filing to vote on increasing the number of shares in the employee incentive plan. Now they're explaining why they need to increase the employee kitty.
Just like ETRM, FOLD had a meeting with the FDA regarding equivocal results:
Co announced positive 12- and 24-month data from its first Phase 3 study (Study 011) of the oral small molecule chaperone migalastat HCl monotherapy in Fabry patients with amenable mutations. Detailed results are available in a slide presentation that will be shared by the Amicus management team on a conference call today at 8:00 a.m. ET.
As previously reported, patients on migalastat experienced greater reductions in GL-3 as compared to placebo during the initial 6-month period; however, this difference was not statistically significant under the original study primary endpoint (responder analysis with a 50% reduction threshold at month 6). Following a Type C Meeting with the FDA in the second quarter of 2013, and based on feedback from the agency at that meeting, Amicus revised the Statistical Analysis Plan to pre-specify the primary analysis at month 12 as the mean change in GL-3 in patients with amenable mutations in a GLP-validated human embryonic kidney (HEK) cell-based in vitro assay.
I like the fact that ETRM's price recovery has been steady and on decent but not outrageous volume. I pity those poor fools that bought MACK premarket a couple of days ago at a huge premium and are now sitting on huge losses.
The real canary in the mine will be the publishing of the FDA reviewer briefing documents no later than 6/13 and possibly a day or so sooner. The FDA claims to try to post the documents at least 48 hours before the meeting. If after reading the documents the canary is still singing, then we can assume the fat lady will sing.
While the consumer price index rose just 12 percent in the period 2007-2012, one diabetes drug quadrupled in price and another rose by 160 percent, according to the analysis by Los-Angeles based DRX, a provider of comparison software for health plans. Source: Bloomberg.
The pros work on fear and harvest cheap shares. Look at HDY: Closed at 1.28 on 4/28 and an unexpected news release today propels the stock to $4. The price on ETRM is being kept artificially low until the BIG POP. I have no sympathy for those who miss out on ETRM as Mr Market kept open an unusually generous trading window to get cheap shares.
Three days closing at $1.88 is a clear indication of market makers and HF trading desks controlling the stock price. When they are ready they will move the share price over $2.
Ade: Your appeal to longs is misguided. Trading bots control the price action, not a few thousand retail longs. You do have to tone down your excessive pumping. VBLOC should be a viable alternative to lap band and gastric bypass, but you wildly overstate future sales.
Paying $140 confers ZERO benefit. The stock will be halted the whole trading day of 6/17 and may or may not trade in after hours. Alan Fierstein at the Street frequently attends these ADCOMS and twitters in close to real time. The briefing documents, posted anywhere from 6/9 to 6/13, will be the big mover, pro or con. The ADCOM vote will be released to the press very quickly and BEFORE any AH trading.
Ade: To refute your inflated VBLOC projections-new products in the medical field rarely if ever bolt out of the starting blocks, sales wise. Remember that VBLOC's weight loss numbers are good, but not outstanding. It deserves to get approved and find a position in the market. As far as replacing lap band and gastric bypass, that is years in the future.
Ade: Your arguments assume a "perfect world" for VBLOC. You remind me a bit of a TV evangelist, who when confronted by objectivity, replies "I have the faith-you don't." Your closing "it is simple math", is simplistic: reimbursement is a complicated process and physicians are slow to change(witness Australia). As an historical example, many doctors for years fought replacing radical mastectomy surgery with partial mastectomy surgery, long after conclusive results were in.
I am long 21,100 shares. Your pie in the sky projections might have some validity if VBLOC had achieved "super superiority" per the SPA. The FDA is giving ETRM the chance to make its case before an ADCOM panel of unknown sentiments.
Took my profits and flipped to ETRM, which has proved profitable. ETRM has a 6/17 FDA advisory vote on their weight loss implant, much less invasive than gastric bypass or lap band. I notice that all the pumpers on this board that excoriated me then are nowhere to be found now(they're probably too traumatized by their losses).
kelvin: The panel ALWAYS votes THE SAME DAY on the voting questions posed by the FDA. Panel members are already quite aware of VBLOC and have read the FDA's briefing documents. Just like Supreme Court justices, 80% of the panel have probably made up their minds before 6/17, with a few on the fence.
yarak: To show you how corrupt the SEC is: after the market crash five years ago, quite a bit due to naked shorting, the SEC acknowledged receiving 4.3 million complaints about naked shorting. Their response! The complaints are "not material."
6/24/13: Pre-split price was $2.05, today it is $.69. Luckily, my outrage at Blum's R/S caused me to sell my whole position on 6/25/13 at avg of $2.02 and make a nice profit. As I said in June 2013, Blum was empire building, would make many tens of millions if CYTK succeeded and even mere millions if CYTK tanked. He has near ZERO skin in the game and shareholders take all the risk: a utopian world for non-accountable CEOs.