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Spine-Tech (SPYN) has developed an implant device for spinal fusion which will revolutionalize spinal surgery. The device has had dramatically effective results. I attended the FDA panel hearing (of outside reviewers) in May and they strongly recommended approval. About 10 days ago the FDA sent a letter to Spine-Tech indicating that the device was approvable if some labelling changes were made and if they agreed to a five year follow-up study (which they had already planned to do). The company has indicated to me that they have already submitted all of the requested changes to the FDA. The FDA has reconfirmed with me that this is on an "expedited" review path. I could not imagine approval is more tah a few weeks to a month off.
The stock is now in the 28 range but has been in the 35 range prior to the panel hearing. The price should atleast meet, or exceeed, the 35 range upon approval. The 3 stock analysts following SPYN rate them an outright buy.
There have been rumors, totally unconfirmed, that Johnson and Johnson is interested in buying them out. Again, jut Internet rumors.
I have much more of a personal stake in this company than a financial stake--due to a back injury I have been awaiting this new surgery for over two years.
Does anyone else follow them or have any thoughts about the device or company or their prospects? Would be interested in hearing other opinions and estimates on how long FDA approval would take (the big unknown black hole).
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