Big Announcement Soon

[Anonymous]

I can only hold my breath for so long...

 

[Anonymous]

Not the warning letter?

The FDA letter is just the "Smoke" the "Fire" is about to burn.

 

[Anonymous]

The FDA letter is just the "Smoke" the "Fire" is about to burn.

Please cite your source.

 

[Anonymous]

The FDA letter is just the "Smoke" the "Fire" is about to burn.

Only you can prevent forest fires.

 

[Anonymous]

Word is Optim breaks down in the body. Degradation leads to breaches. This is why Aortech will not be acquired by a. SJM competitor

 

[Anonymous]

The FDA letter is just the "Smoke" the "Fire" is about to burn.

From MedCity News:
"St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues one

October 17, 2012 9:52 am by Arundhati Parmar | 0 Comments
Analyst Bob Hopkins of Bank of America was mystified and sounded a bit worried on the St. Jude Medical (NYSE:STJ) morning conference call to discuss the company’s third quarter earnings Wednesday.
St. Jude CEO Dan Starks had just done the unthinkable.
He had warned investors that he was expecting a warning letter from the Food and Drug Administration even as FDA was contining its inspection of the medical device maker’s manufacturing plant in Sylmar, California. . . .
Despite the history, Hopkins sounded genuinely surprised given that Stark’s announcement has apparently no precedent.
“I don’t think I have ever heard a company proactively tell Wall Street they’re going to get a warning letter before actually receiving a warning letter or even a 483 (This is the form that FDA uses to document and communicate worries following a plant inspection.). So I think the important question is why did you make that comment. Did the FDA uncover something in Sylmar and told you about it? Or Have you guys uncovered something at Sylmar that you want to be proactive about and have notified FDA about? Can you give us a little more detail there that drove you to make that comment about the warning letter and 483?”
Starks tried to soothe .
“Well, the overriding motive for us is the appreciation that investors do not like surprises,” he told analysts, adding that investors should be aware that in the event of a warning letter, St. Jude has already taken into account its impact on 2013 operating plans.
Starks also commented at length about how everyone should be “realistic about the role that warning letters play in today’s regulatory environment.”
And in a comment that is sure to raise eyebrows from others in the industry who often complain about the regulatory burden, he said the following:
“Another reason we made the comment is that in the long run, we think it’s good for our markets if the public knows that the FDA is exercising its regulatory oversight of medical device companies in a very rigorous and robust way, and it’s clear to us that FDA is doing that.
But provided zero specifics. Starks said he didn’t know what percentage of the company’s Cardiac Rhythm Management products are made at Sylmar, but said CRM products are also made at Puerto Rico and Malaysia. [Later, a St. Jude spokeswoman said the company doesn't break out what percentage of the company's products are made there. But she did say that about 1,720 employees work there.]
As each analyst tried to worm out some nugget of information that might help to frame the issue of the impact of the un-issued warning letter, Starks and a Cardiac Rhythm Management senior executive dodged each question, while apologizing profusely for not being specific.
Two things were clear though – the FDA inspection of the Sylmar plant will end very soon. So a warning letter, if one materializes will come between now and the fourth quarter conference call. And manufacturing plants in Puerto Rico and Malaysia were inspected and those didn’t lead to any warning letters.
Expect the stock to take a major beating today."

 

[Anonymous]

Word is Optim breaks down in the body. Degradation leads to breaches. This is why Aortech will not be acquired by a. SJM competitor

I can still remember a doc looking me in the face and saying: "I hear St. Jude is coming out with a new coating for their leads that will not only improve durability but enhance ease of implantation

 

[Anonymous]

From MedCity News:
"St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues one

October 17, 2012 9:52 am by Arundhati Parmar | 0 Comments
Analyst Bob Hopkins of Bank of America was mystified and sounded a bit worried on the St. Jude Medical (NYSE:STJ) morning conference call to discuss the company’s third quarter earnings Wednesday.
St. Jude CEO Dan Starks had just done the unthinkable.
He had warned investors that he was expecting a warning letter from the Food and Drug Administration even as FDA was contining its inspection of the medical device maker’s manufacturing plant in Sylmar, California. . . .
Despite the history, Hopkins sounded genuinely surprised given that Stark’s announcement has apparently no precedent.
“I don’t think I have ever heard a company proactively tell Wall Street they’re going to get a warning letter before actually receiving a warning letter or even a 483 (This is the form that FDA uses to document and communicate worries following a plant inspection.). So I think the important question is why did you make that comment. Did the FDA uncover something in Sylmar and told you about it? Or Have you guys uncovered something at Sylmar that you want to be proactive about and have notified FDA about? Can you give us a little more detail there that drove you to make that comment about the warning letter and 483?”
Starks tried to soothe .
“Well, the overriding motive for us is the appreciation that investors do not like surprises,” he told analysts, adding that investors should be aware that in the event of a warning letter, St. Jude has already taken into account its impact on 2013 operating plans.
Starks also commented at length about how everyone should be “realistic about the role that warning letters play in today’s regulatory environment.”
And in a comment that is sure to raise eyebrows from others in the industry who often complain about the regulatory burden, he said the following:
“Another reason we made the comment is that in the long run, we think it’s good for our markets if the public knows that the FDA is exercising its regulatory oversight of medical device companies in a very rigorous and robust way, and it’s clear to us that FDA is doing that.
But provided zero specifics. Starks said he didn’t know what percentage of the company’s Cardiac Rhythm Management products are made at Sylmar, but said CRM products are also made at Puerto Rico and Malaysia. [Later, a St. Jude spokeswoman said the company doesn't break out what percentage of the company's products are made there. But she did say that about 1,720 employees work there.]
As each analyst tried to worm out some nugget of information that might help to frame the issue of the impact of the un-issued warning letter, Starks and a Cardiac Rhythm Management senior executive dodged each question, while apologizing profusely for not being specific.
Two things were clear though – the FDA inspection of the Sylmar plant will end very soon. So a warning letter, if one materializes will come between now and the fourth quarter conference call. And manufacturing plants in Puerto Rico and Malaysia were inspected and those didn’t lead to any warning letters.
Expect the stock to take a major beating today."

What Starks knows and failed to reveal is that STJ engineers failed to prove to the FDA the material difference in lead design between Riata and Durata. This failure results in the FDA shutting down the release of future STJ products, including the continuation of selling Durata until measurable and proven enhancements have been made. FDA's view is that allowing a product, that does not significantly differ from a Recalled product should not be sold to the public and represents a health and safety hazard. STJ simply could not prove to the FDA a material difference between the 2 leads.

 

[Anonymous]

What Starks knows and failed to reveal is that STJ engineers failed to prove to the FDA the material difference in lead design between Riata and Durata. This failure results in the FDA shutting down the release of future STJ products, including the continuation of selling Durata until measurable and proven enhancements have been made. FDA's view is that allowing a product, that does not significantly differ from a Recalled product should not be sold to the public and represents a health and safety hazard. STJ simply could not prove to the FDA a material difference between the 2 leads.

Holy shite!!

 

[Anonymous]

What Starks knows and failed to reveal is that STJ engineers failed to prove to the FDA the material difference in lead design between Riata and Durata. This failure results in the FDA shutting down the release of future STJ products, QUOTE]

Likely True.

, including the continuation of selling Durata until measurable and proven enhancements have been made. FDA's view is that allowing a product, that does not significantly differ from a Recalled product should not be sold to the public and represents a health and safety hazard. STJ simply could not prove to the FDA a material difference between the 2 leads.

Not likely. Did anyone see FDA putting Durata's in a locked cage?

 

[Anonymous]

What Starks knows and failed to reveal is that STJ engineers failed to prove to the FDA the material difference in lead design between Riata and Durata. This failure results in the FDA shutting down the release of future STJ products, QUOTE]

Likely True.




Not likely. Did anyone see FDA putting Durata's in a locked cage?

Not likely because they pay off the right people.

 

[Anonymous]

". . .including the continuation of selling Durata until measurable and proven enhancements have been made. FDA's view is that allowing a product, that does not significantly differ from a Recalled product should not be sold to the public and represents a health and safety hazard. STJ simply could not prove to the FDA a material difference between the 2 leads."

Not likely. Did anyone see FDA putting Durata's in a locked cage?

Not yet. The first step would have been to disable any of the order filling. (Note, they'll continue to take orders).

 

[Anonymous]

The conscent decree is coming

 

[Anonymous]

Please cite your source.

Dan Starks in yesterday's earnings call.

 

[Anonymous]

The conscent decree is coming

That is honestly the right response to this issue. They deserve it.

And just to make things political - Obama can claim he's created jobs by having 10 FDA people camped out in Sylmar for a couple years.

 

[Anonymous]

The conscent decree is coming

For us peons in the field. What is that?

 

[Anonymous]

For us peons in the field. What is that?

"If a firm has repeatedly violated cGMP requirements, the FDA may make a legal agreement with the firm to force them to make specific changes; the agreement, the consent decree, is enforced by the federal courts. Usually, consent decrees include fines ("disgorgements"), reimbursements to the government for inspection costs, due dates for specific actions, and penalties for noncompliance. Consent decrees usually are permanent, but at times specified in the agreement when the firm has achieved compliance, it can petition the court to remove the decree. (Of the more than 25 consent decrees issued between 1990 and 2003, only one or two firms have been removed from their decrees.)"

 

[Anonymous]

For us peons in the field. What is that?

It's a Death Sentence to a business. They are rare but exist. Deployed by the Fed's.

 

[Anonymous]

What Starks knows and failed to reveal is that STJ engineers failed to prove to the FDA the material difference in lead design between Riata and Durata. This failure results in the FDA shutting down the release of future STJ products, including the continuation of selling Durata until measurable and proven enhancements have been made. FDA's view is that allowing a product, that does not significantly differ from a Recalled product should not be sold to the public and represents a health and safety hazard. STJ simply could not prove to the FDA a material difference between the 2 leads.

What the FDA will contend is that the recall applies to any lead that has even some of the design elements of Riata; and that include Durata. The consent decree will require SJM to substantiate that Durata differences overcome the similarities.

 

[Anonymous]

Real close now, booooooyaaaaah bOYeee!