I've seen nothing from GNVC since they indicated that Novartis had the right of first refusal, no doubt what they're developing is at an early stage of development. I would hope that in future quarterly reports they may say something more, but I doubt if they're anywhere close to clinical trials of the new product.
I would hope that the current Phase I is close to reaching the highest planned dosage level. Once that's been achieved, perhaps we'll learn about the Phase II portion of the trial. I believe they're limited on what they can do Phase II to dosing more patients at the dose level determined to be most effective, but I could be wrong about that. I don't know that if they believed that more than a single dose would be more effective, they couldn't gain FDA approval to do that either expanding the Phase I portion, or in Phase II.
I believe the FDA has become more responsive to what drug makers wish to do, but I have no proof that they wouldn't insist on a new trial to multi dose patients, if that's the next direction they want to take. By this time I believe they know that some improvement is being seen, but I believe if the improvement were sufficient to restore intelligent speech, we'd have heard about it by now. The question may be, will even greater than planned dosages produce better results, or are multiple doses required, or finally, do they need that supplemental drug being developed by GNVC to truly restore intelligent hearing.
To me, another possibility is, can hearing aids, along with GNVC's treatment, produce better results than what can be done by hearing aids alone. While the goal may be to eliminate the need for hearing aids, if it isn't achieved, but if a combination of the drug and hearing aids does improve hearing, isn't that sufficient to gain approval.
Gary
AI
