Yeah, I agree. On their website, they cite ease of manufacturing as one of the advantages of their PCA approach:
It will help neurotinnitus caused ONLY by inner ear damage. It will not help pulsatile and somatic tinnitus, nor help middle ear related damage. But, these tinnitus issues have their own separate treatments that address the root cause.
I don't doubt Astellas already has the know-how and capability to make the drug. Safety concerns do make sense, they don't want to invest in producing large quantities to end up scrapping them, or harming people and end up in a class-action lawsuit.
Do you believe companies never hide behind the FDA process in order to bilk investors on drugs these companies know will fail?
I have experience. You've read the FDA comic books about how they are from the government and here to help?
The FDA is a spoon fed entity of overrated sh*t. A type of monopoly.
Despite all the well meaning public statements, Frequency Therapeutics is a for-profit company with stockholders. As a business, it doesn't make much sense to use that $42m fund on expanded access. It's better for them to quickly go through the whole clinical trials shebang for quick product release. Frequency Therapeutics still need the capital to establish phase 3, then setup larger production, marketing, etc. Despite many people having hearing loss and tinnitus, it's still not well known to the majority.
I am hoping these two will be successful too, and I am hoping that FX-322 will be successful for many. I have bought about 15 shares.
My audiologist said that all tinnitus is caused by hearing loss (brain creates a sound to fill in for hearing loss) but the tinnitus may be be manifested in different ways/pathways (auditory nerve, neck (spinal nerve), etc.).
I'm sure it will not help pulsatile or somatic tinnitus. Not all tinnitus is caused from hearing loss. If you have pulsatile tinnitus, then it's a blood circulatory issue. The blood circulatory issue needs to be resolved. If your somatic tinnitus is from a pinched or irritated auditory nerve from tmj disorder or neck issues, then like pulsatile tinnitus, that person need to resolve the TMJ or neck issue. These are not caused by hearing loss. Restoring cochlear damage will not help pulsatile or somatic tinnitus.
Eh I would say all tinnitus is caused by hearing interference, not loss.
I agree with most of this, except for the press release from FREQ re: the $42MM placement;
I think we will see positive results with both Dr. Susan Shore and FX-322.
There is definitely more than one support cell per hair cell based on all the diagrams included in papers I have seen.
Here are a couple of diagrams that can help flesh out your understanding of the different kinds of support cells, and the ones that are LGR5+.
While I agree with this chain of thinking and have posted as much before, I think it takes a certain amount of cynicism to believe that Frequency isn't genuinely looking at Expanded Access after Carl LeBel just said on the Tinnitus Talk Podcast that it was something that they are "certainly interested" in.
So it looks like this method can restore 1/3 of lost OHCs. Therapeutic, for certain. Hopefully this is the stepping stone to getting the next round of regeneration, though. Or that the IPC can work for that first OHC as well. Then it would be 2/3 of OHCs.
I don't think you can extrapolate percentages from a schematic. Besides, that's 2-D drawing, we would need multiple views to assess that because even going by the first drawing it looks like one row interacts with the LGR5+ cell and in the second, one cell interacts with two hair cells.
You tell me that a for-profit pharmaceutical company is not going to try to get something out as quickly as possible
Can you please explain what is the flat epithelial stage and what that entails? I was doing self pure tone measuring and I can not hear 15 kHz at all at any volume while my good ear can hear 15 kHz at the lowest volume. Is complete or near deafness at that range considered flat epithelial?
I'm interested in this too, although my audiologist told me that there are some serious limitations in doing testing at home. Headphones, the volume, the ability at being able to hear certain frequencies all come into play. I have been told that these tests could in theory be accurate but in reality they probably are not at all.
Flat epithelia happens with profound hearing loss (greater 90 dB). I'm not sure of it is an acute or chronic feature of that sort of loss but it's associated with it.
This is true however the phase 1 results would indicate that there could be serious truth to this theory considering the 10 dB improvement at 8 kHz and word scores getting better could be considered significant.
Perhaps, but it should be sufficient. The fact that I can hear 14 kHz and 15 kHz very noticeably with my good ear on the lowest volume but I can not hear it at all on my tinnitus ear (even 5x the original volume) is sufficient enough to conclude that I have damage in that UHF range. Also, since I can hear how 15 kHz sounds like in my good ear and my tinnitus sounds almost exactly like 15 kHz is elucidating enough.
Surely, the proceeds will go towards the development of FX-322. While Frequency Therapeutics is also working on a Multiple Sclerosis therapeutic, FX-322 is their leading drug candidate. It shows promise, has a massive target market, and is the closest to approval/release. The private placement is directly tied to this drug.
As an aside, the ear isn't supposed to have the same sensitivity to different frequencies:
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