Walkingshadow :
If you check BDNF history (clinical trials results and literature) for last 3-4 years, you will find that: 1. ALS is one of the hardest to threat diseases and 2. neurotropic factors (like BDNF) have small chance (BBB protein factor) for success. Said this, I am slightly positive that REGN will one day (as Rick said: By 2202 year) get FDA approval. However, REGN /AMGEN have low lever priority for this program. REGN is preserving cash (if you didn't know P&G are solely responsible for PI expense, but they share equally PII and PIII cost) for something more important. This is reason that REGN is delaying start of the new BDNF PIII trials for late this year, until data for AXOKINE PI trial are available. So, if safety data are good and hint of drug efficiency are obtained, all other has less importance. REGN will be seen without filters.
Regards the gene therapy for ALS, it is pure science-fiction for now, imo.
Miljenko
PS: Rick, bait or not, I do not see any fish. But, with some unexpected sea-current near shore, fish can come in surprise time. |