I called neuralstem the other day to see if they had applied for the FDA's new break through designation statue. Not only have they neglected to apply...they were unaware of what i was referring to. Any longs on here who want to see this company succeed please call them today and stress the importance of applying for this designation. 3 drugs have already been approved this designation which allows them to go straight to market after phase 1 safety only.
When an investor makes a good faith call to "investor relations" the job of the employee is to take the information and forward it to the proper responder. It was a fair question to ask and a timely response should be offered. If in fact the company believes this designation is not appropriate a simple "thank you for your support and interest" is all that is required. If the office of investor relations was more transparent on questions like this there might be less acrimony developing on this board. It seems that Nate is doing his research and that he is trying to advocate for all of those who just complain and call for selling short or just getting out of the stock. By his investment he is an owner and as such has the right to provide the company the benefit of his research. The CEO likes to blog a lot so perhaps he could spend a few lines educating us on the new paradigms being developed regarding Breakthrough Therapy Designation and weather any of CUR programs may now or in the new future be eligible for consideration.
Nate, than you for taking the time to report your concerns. Please continue your relationship with the investor relations department as I am sure that they are professional and as such want to serve the best interests of the investors.
I'm sure "some guy shareholder" on the phone is going to give them information that will change the entire outlook of the company and the future of stem cell medicine.
Although there is a Breakthrough Therapy Designation (BT), I have faith the people at Neuralstem know what they are doing. I doubt your little phone call will do anything except #$%$ off the person answering the phone...
You say it doesn't exist? You want to explain to me then how 2 separate companies and 4 different drugs have been granted breakthrough designation. Pharmacyclics and Phizer both were just given the designation by the FDA. Do your research bud
They were unaware of such a new "break through designation statue" [sic] because it does not exist. No drug can go to market without demonstrating efficacy, which a phase I study cannot do. They already have listed their spinal cord injury trial on clinicaltrials dot gov. They are moving in the right direction, and the science is as strong as any cell company out there. Don't encourage people to pester the Neuralstem secretary with stupid questions.
"They were unaware of such a new "break through designation statue" [sic] because it does not exist."
It may not exist yet, but somebody could make one. Just imagine, a sculptor could create a pair of statues as an overall work of art. One could be called "statue of limitations" [not sic], the other could be called "break through designation statue". The "statue of limitations" would be of a person holding their arms in a restricted position, unable or afraid to reach for success, unable to reach out and embrace life, etc. The "break through designation statue" would show a person who is reaching out, breaking the bonds of their personal restrictions, embracing life and success. It would make a great pair as an artistic whole.