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.
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.
Question is when will the FDA approval happens? It should have happened by now, but it is getting delayed. I don't know what forces are behind this delay. If the delay is done purposefully to benefit some, then SEC should intervene.
So much for hiring a turn around specialist. He will delete the common shares, pay 5c on a dollar to the debtors, issue new shares for him and his cronies, shut down many stores, and keeps profitable ones and reap the benefits. Common share holders get the tail end of the shaft. He could have just broke the lease on non performing stores, paid by holding firesale of the remaining merchandise. Anyways will keep the shares to see what happens. Holidays are near.
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.
This guy is diverting attention to other stocks. I think he as an agenda to take advantage of longs who are frustrated of low price in ETRM, and pull them to other stocks.
If Biglots can survive in large metros, so can these people. Today Wet Seal hired back their former ecommerce guy. These guys should pay top dollar to hire someone to drivr ecommerce or outsource the website efforts and get it polished.
Good questions. It is for them to find the answers and make it work. I just gave an idea which might work. Their cost of doing business is more than they bring in the money right now and I believe many stores won't see any significant foot traffic to justify to stay in business. Those stores need to be closed.
and open in crowded areas like metros. Close 5 stores in remote areas and open 1 store in metro. It will bring more money and they can become profitable. For remote areas, serve them through website. It is same as Big Lots and can become profitable.
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.
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.
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.
could be. Ask went up from 1.12 to 1.15 by the time I bought my shares. Later on HFT and stop loss by short might have taken over..