Seems like a lot of the old conversations are coming back to this board. The facts are in the reports.
As for the FDA, there is no such thing as a CRY approval. The FDA recalled tissues of a stated period with minor exceptions that are released under specific guidelines. Remember the term RECALL. Additionally, CRY also was required to submit a corrective action plan to resolve the issues that caused the recall. So CRY submitted the plan and FDA extended their agreement which means they have agreed with the plan or at minimum are working through any issues related to the plan. Don't think for a second that the FDA extended the agreement without reading the Corrective Action Plan...
The FDA will not change the restrictions of the tissues under the recall period unless they can prove the objective quality evidence which is very unlikely. That's why they were recalled. Restrictions on those tissues remain in place until they are all used.
Now for the remaining actions we are waiting on. At some point, CRY will state that the FDA has agreed with the Corrective Action Steps that were implemented and they are back to full procurement and processing. All this will mean is ortho is restarted, they do not require a doctor's perscription unless tissues used are under recall (ie, no OQE), and FDA is back to normal auditing.
Why do people think there is an FDA "Approval" stamp out there. There is only the FDA agreeing with the corrective actions and CRY going back to full production.
There is only one thing affecting the short term pattern of this stock and that is full production. We will here ortho is back or a date given, bio-glue continues it's growth rate and CRY and the FDA have agreed on the processes. As for what will cause movement - it is only how much market share the company has held. We really lost 9 cents per share last quarter and if CRY can make that up, the shorts will cover.
Hate to be shorted if they don't have a loss and are just now getting back into ortho...
Sorry I did not know you owned CRY and this message board. I think that you are the shorty just waiting for the stock to go up to get your losses back and then leave. What makes you the EXPERT. If you can't handled other peoples comments you shall be the one taking the hike and hide until the Canadian Sect rescues you.
You may be right, but keep in mind that CRY is on the back burner and has to prove that this time. Any CRY request for re-inspection that shows a fixing rather than a systemic plan might be seen as lack of a genuine management commitment to improve the safety procedures.
The bottom line, whether or not you call it approval (and I agree with you that many posters seem to be confusing an FDA submission approval with what CRY is waiting for, a lifting of a recall), is that CRY expected, by December, an on site reispection/audit of its quality system and process validations that were pointed out as being deficient in the 483 by the FDA. They need FDA "approval" of its implemented corrective actions in order to void the recall and begin harvesting and processing ortho tissues. They were expecting to ship ortho tissue in the 1st quarter of 2003. The January 15th deadline is being brought up by some, due to the confusing wording that implies it may be the final extention and some decision will be made by then. In any event, if extended, it would still preclude the shipment of ortho tissues, and would cause more cash burn. The 15th is not likely to be good news.
Parker - we agree on some points but the FDA recommended that CRY get a separate auditing firm for verification. While CRY mentioned full reinspection by the FDA, I do not know of any statement by the FDA that indicated they would do a complete reinspection. The FDA recommended another firm so they can review results and spot check without being the final QA authority which has never been the charter of the FDA.
Now as far as this inspection, how do we know it has not been done. CRY could be procuring and processing tissue right now Iwith processes observed) and have no obligation to report to the market. In fact, the only way to prove they have implemented corrective actions is to perform the process. Also, iot ship these tissues in 1st qtr 03, they have to have the approved process tissues on hand. Don't make the mistake in assuming they are doing nothing on ortho tissues.
Now as far as the recall, the recall will never be lifted on prior tissues unless they are validated. The new tissues will have no recall as they will be processed iaw current regs. The only thing CRY is waiting for is FDA stating current processes are validated and they will only tell the company.
Now on Ortho, are you now stating if we throw ortho away and we never touch it again that the company will fall? Many discussions from you in the past indicated as it well is a small portion of the overall revenue. Also, what do you think earnings will be?
Well said. I'm curious (as I'm sure others are too) as to the contents of the action plan.
If the plan involves validation studies to substantiate processing methods, we could be in for a long ride.
It's in the hands of the consultant(s) and executive management.
Good Luck to us all!
While there might be validation process discussions between CRY and the FDA, I doubt these processes are part of the corrective action report. FDA's only interest is CRY meeting current requirements and the biggest being the chain of custody for each tissue. As for other issues CRY has with the original FDA discussions, I think those are being handled separately from this report and will in the future generate new rules across the industry.