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rocky301

05/27/11 10:34 AM

#32078 RE: copper thorn #32077

copper thorn,

Welcome to the board.

You asked,
"How much training and equipment would an opthamologist need to administer this treatment?"

In the scheme of the clinical trial, I view this as probably the least to be concerned with. Below are a few blurbs from the past.

"Finally, the mechanism of application is a needle. Unlike most appliance applicators, it does NOT have to be approved by the FDA. A needle is recognized by the FDA as a standard mechanism of application and even more importantly every eye surgeon utilizes a needle in surgical procedures dealing with the eye. Therefore, you don’t have to teach the “old dog new tricks” which is a huge barrier when normally introducing new therapies utilizing a delivery device."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=41946204


In our particular situation, we are inserting a needle into the eye- which is something that is done all the time, by the way, this isn’t something that’s foreign to the practitioner that does the application- but our application takes place only once or possibly twice over the life of the patient. It is our expectation that the therapy which we’ll apply will have an impact on either slowing down or arresting the progression of the disease. We’ve seen that in our animal models. There have been some very dramatic results when we’ve applied it into animals and we are extremely hopeful that we will see the same types of results when we apply it into humans.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57868481


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rumit

05/27/11 10:40 AM

#32079 RE: copper thorn #32077

Good post copper, EOM.
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rocky301

05/27/11 11:49 AM

#32080 RE: copper thorn #32077

copper,

It seems to me that at that juncture -- when you have an approved treatment, we would need the support of a major pharma to get the treatment out on a scale commensurate with demand

NO doubt about that.

(recent PharmaTV Interview)
Gary Rabin:
"Well right now we obviously are deficit funding ourselves through our own capital, ultimately we enforce plan to commercialize this product probably in partnership with a large pharma or a biotech that has penetration into the ophthalmology surgeon market and the therapy that we are doing is the subretinal injection 50 to 200,000 RPE cells suspended in ceiling 150 micrometer of ceiling, so this is a very easily scalable, transportable model that looks very much like a traditional pharma product or a biologic."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=62474597

(conference call)
I just returned from Europe where we had some great meetings. As far as the RPE program goes, it would be highly premature to seek partners early in the phase 1 study as we are hopeful that even though we are dealing with late stage patients, we will soon have data on retinal engraftment of our cells, and thier impact on photorecptor function. If we see no safety issues, and are able to detect some engraftment of our cells to the photoreceptor / Bruch's membrane, we will obviously be dealing from a much stronger valuation and negotiating position.