Thanks. I was looking something inline with other implantable devices. Me too not familiar with medical devices. The reason I asked is, most weight loss solutions comes with a list of warnings. If at all any warnings for VBLOC, how the price is played out? Will investors think it is yet another weight loss with side effects? Just curious and with a bit of concern.
Sentiment: Strong Buy
While I agree with your analysis, I would say ETRM is not a procedure company. It is a device company where hospitals or surgical centers place orders, buy the device and perform the procedure. They are the ones who needs to worry about reimbursement. However, It is in ETRM's best interest to have good relationships with insurance companies, so that they believe in the device which results in faster reimbursement. ETRM is like any other company which sells its products on 30 or 90 day credit terms. Only thing that is not for sure is, how many surgical procedures will be done, but for every procedure, they sell a device.
Hopefully between tomorrow and 12/19. Last two weeks are holiday weeks and FDA folks will be on vacation. If not, next year, but approval is a definite thing.
what do you think Medtronics will pay? I am not looking at stock price, but market cap. Right now it is 96M. Will Medtronics pay 250M, 500M, 800M or 1B to acquire ETRM?
I don't think ETRM has the capacity to go alone, given the inept management and their dysfunction action of paying them and employees bonus in the wrong time. If nobody comes forward to buy, they issue more shares to raise the money for keep the company going.
It is in their best interest, that Medtronics or other big boys acquire them sooner than later. All your feedback is welcome.
Platguru, can you please justify why it goes to 1.20, when the trend is up for ETRM? It is nearing earnings, obesity conf is going on, FDA decision will be soon. What is your opinion here? Just want to understand your perspective.
FDA comes back with needing more information and stock price falls? I am trying to find out
who are investors, who are speculators? I own 60k and bought anticipating FDA approval and based on positive ADCOM recommendation.
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.