This is certainly a sign that GNVC is alive with ideas, the question is, how will they fund their efforts. While this could be done with grants without dilution, even they require substantial effort. I suspect that barring a partnership for something GNVC is developing, we'll hear about new funding sometime before the end of the year, probably sooner, rather than later.
I would hope that at some time in the near future we learn something about the supplementing hearing drug which Novartis has first right of refusal to. I believe that the current drug is having some positive effects, but by itself, in a single dose, may not produce results sufficient to gain approval. I believe that Novartis will continue working with the drug, and they'll determine whether multiple doses, a supplement, or both may be needed before approval is possible.
Of course their is another possibility. If hearing improvements can be supplemented with a hearing aid, perhaps people who currently can't hear will be able to, and likewise those with limited hearing with a hearing aid may be able to hear better with an aid after treatment. This could certainly be another path toward approval.
Approval clearly would put GNVC on the map, but if it requires substantial additional testing, it will take substantially more time, and GNVC will be hurting for income due to the delays. As is, they have $5 million due with the initiation of a Phase 2B Trial. To me it's doubtful if they'll run the 2B portion of the trial until they have a protocol they believe has the potential of approval. If they initiate a multi dose trial, I believe that would be considered Phase 1 as they seek to determine the protocol that achieves the goal, once that's done a 2B Trial could be initiated.
Gary |
