Concerns have risen over the Boston Scientific (NYSE:BSX) review process, and Wells Fargo (NYSE:WFC) analyst Larry Biegelsen said it could take up to 135 days for the process to play itself out.
Other analysts watching the situation say they have hopes it could take a much shorter time; hopefully a four to six week period from the moment the issue was identified. While that is the hope obviously, it’s far from a surety that it will be what actually happens.
Boston Scientific chief executive officer Ray Elliott has stated the company isn’t getting any signals they are going to be expedited in the review, and “It appears we will have to wait our turn in the queue.” Elliot’s comments were made in a filing by Boston Scientific with the SEC.
All of this stems from the discovery the company hadn’t properly filed the paperwork with the Food and Drug Administration in relationship to changes in the manufacturing process. Consequently they had to pull all their defibrillator products from the shelves until it is resolved.
The company reinforced they’re have a strong financial foundation and it hasn’t been compromised by the disruption in sales of its defibrillators, which accounts for approximately 15 percent of its sales in the United States.
If the review process extends far beyond what they hope for, close to the 135 days suggested, it could cause some major damage to Boston Scientific’s revenue and profits for the quarter, and for 2010.
