Gene - I hope they correct the white staple bleeding problem, then make sure lock-out mechanism works to limit tissue correctly so that stsple line will hold. Let x-45 handle thicker tissue issue. I would like a salaeale
product out asap. No one failed to bring up replacement of Knodel for R&D at last Conf. Call. Did They replace him yet? Will his departure slow down the corrections needed for x-30?
GSA - Very possible and plausible. With of all the previous marketing failures of Cardica, I too see them only doing a limited launch to show that microcutter is wanted by surgeons, Then negotiating the most favorable deal with a large money'd partner for US and EU. There would also be a push to buy-out CRDC outright, by a large player at that early stage
to get Crdc and their IP at a steal, before Microcutter suite is fully completed. The new BOD, will have to consider all options available. Most likely we small fry s/h's will never know until a deal ialmost done only needing s/h approval through a vote.
I see the Japan approval as 1 even though more delay could occur with changes being made to device which might require some kind pf further approval, Also New BOD composition that is weighing all alternatives available to crdc. It also appears that their undisclosed timeline for a fixed device might not be as long as thought if they are still retaining a salesforce for US, Germany.(If it was long-they would have dropped all but 2 for Cardiac products as before) Any more from you posters?
Right on target Gene!!!! The key word is Uncertainty!!!! Can they figure out the problem, Fix it, or can't they. Not a whole lot of guidance on that. Also not a lot of credibility with "The Founding Father" regarding timelines.
Now that Knodel is gone? Hausen? One would think they need someone like Getitdone to take the reigns in that department. Also, I wonder how much cash was pd to Knodel for his termination that occurred Jan 7th after Qtr end.
Back in November of 2014, they stated that X-45 would begin testing in Humans by year end. One would hope that they are close to having a working model. However, one never knows if Hausen is telling the truth on that front. Also one doesn't know the extent of "De-prioritizing" means in Hausen speak. Thanks for sharing your knowledge of development
in this area. It defineitely helps understanding the steps involved with this product.
Assuming they can figure out problems with X-30, How long will it take to complete x-45, and begin testing in humans, then CE mark in EU, then 510k approval in US?
The Exchange 30? Since 2nd qtr calander yr 2011? It has been so long, with so many iterations I can't remember. I wonder how much help Lee Swanstrom, Med Drector has been involved?
One has to wonder whether an offer by AMC was made 1 1/2 - 2 yrs ago
but was turned down unknown by shareholder's. I bet now we the s/h's would have loved to take it.
At least Jimmy Swaggert apologized for his behavior, You will never hear the "Founding Father" do that......That is called arrogance. Since 2010 I have heard Time tables and Estimates time and time again that have been so far off the mark it is truly amazing that he has survived as CEO. He has not been "Held accountable". Too bad for us.
Thx for the informed info Getitdone. I too wondered "what the heck is wrong with
not developing the x-45 too. It seems like these people...60 plus..can't accomplish much....not concerned that cash is running out, and time is of the essence. I guess it goes back to leadership and meeting deadlines.......Those not readily found in the "Founding Father".
If device is ready in future, sounds like back to Controlled, snails pace launch as before halt/recall.
Cash will be too low for anything else, unless another massive dilution with new secondary offering.
GSA - When I listened to c.c. It sounded like they needed large sample size of test subjects for FDA approval for vascular use (White staple) Isn't that label expansion from current approved use? Am I incorrect?
Your analysis before Conf. Call was spot on Getitdone. What time frame will it take for all of this new testing to be completed, with a competent x-30 to be ready for sale again? Any best guess's?