Folks...there's nothing wrong with the defibrillator units. Only accompanying documentation. Once the documentation is edited and properly published, the FDA will give the all-clear signal, sales will resume and the stock will rise back to normal levels. This is still a buying opportunity.
30 recalls does not sound too attractive. I am surprised the total is this high. When BSC took over they hired statistician to help improve the quality systems. I was shocked when the problems showed up after all of the training that the engineers had.
this is what i found from another site:
not my window of experience. if the last phrase is to be true that is not good news.
Exclusive: The FDA clarifies the BSX recall PMA process
March 26, 2010
The HCC has obtained some exclusive feedback from the FDA regarding the length of time required to turnaround the PMA supplement process related to the changes made to the BSX ICD line. Recall, all of BSX’s ICD products have been pulled from the market after it was discovered that the company failed to properly follow FDA protocol when BSX made unknown changes to the manufacturing process.
First, The HCC learned that it is a 30-day PMA supplement, as was rumored yesterday by JP Morgan analyst Mike Weinstein who quoted a WSJ reporter. That is incremental good news given that it could have been categorized as a 180-day process. However, it must be emphasized that the “30-day” time period is completely arbitrary and that the FDA is not obliged to complete the process within 30 days as if it were a PDUFA date.
The FDA provides data on average turn-around times for “30-day PMA supplements”. The FDA wrote (bracketed comments are from the HCC):
“Since FY 04, the average total FDA review time from receipt to final decisions (i.e., approvals and other final decisions such as withdrawals and conversions) for real-time supplements [30 day supplements] has remained fairly constant between 62 and 67 days. It decreased to 46 in FY 08 due to new performance goals. Since the average review cycle for a real time PMA supplement is one cycle, the average FDA review time is approximately the same as the average total elapsed time. MDUFMA [a user fee program] has resulted in a significant increase in the number of real-time supplements received by CDRH. ”
It is important to place those statistics in perspective. The fastest turnaround time was 42 days, but that was under the CDRH led by Dr. Schultz and President Bush. CDRH has undergone a complete change in leadership primarily because CDRH was too cozy to industry.
Yesterday, JP Morgan’s device analyst, Mike Weinstein (and Wells Fargo’s Larry Bigelsen), was somewhat discredited when a WSJ report specifically rejected the notion that the FDA was prioritizing the BSX PMA supplement in an expedited fashion. Mr. Weinstein had written on March 17, “(BSX) has a good chance of getting this resolved in the next week or two with the outside risk being 30 days”. Mr. Weinstein was basing his optimism on comments from BSX sales reps. The HCC cautioned that those were unreliable sources. After the WSJ article yesterday, Mr. Weinstein wrote that April 16 is the likely date by which BSX will have the PMA supplement resolved.
Based on what The HCC has learned, it is likely that investors are still being misled by overly optimistic sell side analysts. Even under an industry-friendly “George Bush” CDRH, the average turnaround for this type of PMA supplement would be 46 days, which would be approximately May 1st. However, given the overall corporate warning status on BSX and the new, more safety conscious CDRH that is overhauling the entire 510K/PMA process right now, the prudent investor should expect at least 60-days to transpire before any resolution to the ICD recall is made (i.e. May 16th or later). It should also be noted that there is a real risk that BSX does not have the required animal and/or bench data required, which would translate into 6-months or longer in delays.
Koolaid drinker I ain't. Believe what you want. Your choice. Standard practice in the industry, regs. say 30 days from the time a manufacturing change is submitted till FDA must respond. But why am I wasting my time. Probably same guy with a new handle oldest trick in the book
So many idiots and so little time to f%$# with them. This board is filled with Koolaid drinker that only believe what they have been told. That or just pure emotion.
Greed and emotion have to be removed. Going to leave you a seperate message starting a new topic. Very curious on your thoughts.
Keep up the great work. Gotta make this next message quick because my Mommy thinks I have been in bed for over an hour.
I thought you were supposed to be in school at 9:05 A.M. In your next to last post you stated. and I quote. "I only have 2 minutes to finish this post before my mom has to take me to school." and I am the one all over the place. I am and have been consistent. I would put a Cognis or Teligen in my mom and I have stated why for the third time. I am making no bones about who I am! Still haven't gotten that from you. I always consider the source or who the author is of anything that I ever read. I have not been all over the board. I don't think you are a school age person from your posts and I do think that you are a competitive rep. slinging mud on your competitors board. In previous posts that I found through your handle you spoke of being in the implant community.
So I am to believe that you are in the implant community and an under 16 year old person getting rides to school from your mother. WOW boy genius......... Come on
OWN UP TO WHO YOU ARE AND GET REAL
OK, I've seen all the commentary and understand the sentiment. This issue is going away soon and an organization learns from something like this.
The 10% pop when FDA does approve (and when they do, that will prove the premise correct; if they don't approve, longs would have been wrong). It was encouraging that the FDA came out with the statement about not reviewing in an expedited fashion. That means they are working on it now. No news could have meant a longer time for response...
03/25/10 02:52 pm ET ... S&P UPGRADES SHARES OF MEDTRONIC TO STRONG BUY FROM BUY (MDT 45.21*****): We see the recent approval of MDT's MRI compatible pacemaker as evidence of MDT's R&D pipeline bearing fruit, and we see MDT gaining share in the pacing market and other emerging product categories, as products are released. We also look for MDT to gain share in the implantable cardioverter defibrillator (ICD) market from competitor Boston Scientific (BSX 7**), on BSX's ongoing product recall issues. We raise our FY '11 (Apr.) adjusted EPS estimate by $0.06 to $3.60 and our target by $6 to $57, assuming MDT trades in line with peers, giving its improving growth profile. /J.Englander-CFA