I had a bid for 1.12, only 4k shares got filled. I had an order for 20k and waited for a couple of hours to fill, but nothing happened, because the ask jumped to 1.13. I converted 1500 to market order, soon ask price jumped to 1.14 and my shares got filled. Again I did 10k to market order, ask jumped to 1.15 and my order got filled. Looks like it frayed some short's nerve, soon price jumped to 1.20 and closed there. I have the satisfaction of having triggered some fear in shorts. I encourage everybody to do this so that we can take the price back to 1.50 range.
My total shares - 60k at an average price of 1.45.
Congrats. Before one should buy a stock, they should ask themselves whether you sell the stock or buy it at the current price. If you think it is not a sell, then buy more. I did that too, and value at this level is cheap and it is not a sell.
for the approval. After adcom, is there any deadline FDA should meet or do they take their own sweet time?
Looks like FDA is waiting for something, not sure, for some big buyers close to the panel members to accumuate enough shares. Maybe some company eyeing to acquire ETRM is accumulating the shares silently and has some panel members in its pockets..
I feel we are due for approval by oct 15, but it all depends on FDA.
I think you should continue to post. I like the entertainment from you and ade, and opposite perspectives. I need some of the entertainment to diffuse the tension created by waiting for FDA approval.
Has anything changed from last week, or before last week, other than price? If you react to day to day price, then you are day trader, not an investor. FDA will meet today and tommorrow for medical devices events, hopefully we may see some news. It is better for the company to be silent at this point. If you have no hopes for this company then it is better to sell and move on. Posting negative information, panicking or even posting concerns will create a bad impression among other investors who would keep it to themselves and wait for the approval.
From ETRM 10-Q
As a result of the positive safety and efficacy profile of VBLOC therapy, we used the data from the ReCharge trial to support a premarket approval (PMA) application for the Maestro Rechargeable System, which was submitted to the FDA in June 2013 and was accepted for review and filing in July 2013. An Advisory Panel meeting was held on June 17, 2014 to review our PMA application for approval of the Maestro Rechargeable System.
So they took almost 1 yr for Panel review.
From FDA site..
Within 180 days of the date of filing of the PMA (§814.40), FDA will complete its review of the PMA and of the advisory committee`s report and recommendation and issue one of the following:
•an approval order under §814.44(d),
•an approvable letter under §814.44(e),
•a not approvable letter under §814.44(f), or
•an order denying approval under §814.45.
So according to FDA it takes 180 days. Lets say it takes more than 180days, but almost 1 1/2 yr? (from July 2013 to Now).. That is what I am talking about..
I suspect either FDA is severly understaffed or they delibirately delaying the approval and I don't know the reason behind it.
Will the new information about CE mark amendment delay the FDA approval? Do they need to file new information with already submitted paperwork? Just want to understand no additional paperwork required, which might delay approval.
This is where ETRM comes into picture..
Yet it's been an uphill battle for developers of obesity treatments. Two years ago, Arena Pharmaceuticals and Vivus got approval for the first new obesity drugs to market in the U.S. in 13 years, and a third new drug, from Orexigen Therapeutics, is now under review at the Food and Drug Administration.
The area had been plagued by safety concerns, including the withdrawal of some drugs like fen-phen, a combination of drugs that was pulled from the market in 1997 after it was linked to heart-valve problems, and Abbott Laboratories' Meridia, which was taken off U.S. shelves in 2010 after it was tied to heart attacks and strokes.
One question is when is the FDA approval? Will FDA approves/dissaproves out of the blue, or they inform a specific date that will approve? It is this uncertainity that is causing price to drift downwards and is at the mercy of shorts and day traders.