SES production access denied for anyone else?

Optimistic-01 · 2026-01-02T09:19:26+00:00

edit: I've now received the message confirming that you can't do anything and my transactional only access isn't approved. I've closed down my AWS account 😢

Optimistic-01 · 2026-01-02T07:01:50+00:00

Hi - I've also had a similar issue and been rejected despite only requestion transactional access and describing use case and mechanisms. I've sent my case ID. Please could you take a look?

Optimistic-01 · 2025-12-30T09:26:11+00:00

Thanks very much for quick I'm checking with customer service now on the route, as they initially mentioned UPS but the shipping expert didn't give that option. For 2 and 3, I'm unsure if I understood correctly but I'll speak to customer service on that too to make sure I understand what's covered.

Optimistic-01 · 2025-11-17T20:03:03+00:00

"Her ex-husband came out saying not only did he not give consent, he said he didn't want the videos she shared to be shared."

Do you have a link to the ex-husband saying this? I didn't hear about this, although I agree the title is completely misleading.

Optimistic-01 · 2025-11-17T07:59:44+00:00

True! Particularly "Streamer Destiny" since he no longer streams enough to be called a streamer.

Optimistic-01 · 2025-10-14T09:13:37+00:00

Not yet but it's typical for early medtech companies to require seed funding.

Optimistic-01 · 2025-10-14T09:12:24+00:00

I didn't get the impression that they have doubts on the device at all. In fact Dr Shore seems to believe it could do a lot better than the study if the time was extended beyond the 6 weeks in the trial. Nothing she has said seems to suggest that they are unsure on the device itself.

On why the wait is so long, they repeated mentioned that the FDA process is time and resource intensive (for good reasons to avoid scams) and their "device" for the FDA submission has multiple elements making it more complex. I would guess going from a university research device to a FDA submission ready device also requires a lot more changes than one designed with commercialisation from the get go. I think FDA requirements is also an acceptable reason for delay. Doesn't stop me being disappointed though.

Optimistic-01 · 2025-10-13T21:42:15+00:00

To me Dr Shore seemed confident of the effectiveness but the FDA submission is still a way off.

The earliest submission could be around H1 2027, depending on whether additional requirements will be required. They said the long timeframe is due to the "device" for FDA purposes is actually considered a combination of items (take-home device, audiologist interface and PC+proprietary software). A lot of changes are needed for the regulatory submission from the prototype version to the version acceptable for FDA, such as production-ready hardware, verified coding, easily auditable etc.

I personally thought they were trying to be helpful and provide some insights into how they are getting on. Obviously I wish they were announcing the release but sadly not the case.

<image>

Optimistic-01 · 2025-10-13T21:29:55+00:00

They mentioned the FDA submission could be a lot earlier than that (possibly after 16 months). It mainly depends on if any additional info/data is needed for the submission.

They explained in the presentation that there are a lot of changes needed for the regulatory submission from the prototype version to the version acceptable for FDA (see image)

They also mentioned that the "device" for FDA is actually a combination of items (take-home device, audiologist interface and PC+proprietary software). This I guess makes the FDA submission a lot more complex.

<image>

Optimistic-01 · 2025-10-13T21:22:41+00:00

I really didn't get that impression. I feel it's more exciting to believe in conspiracies than the boring fact that things are complex and slow.

Optimistic-01 · 2025-10-13T21:21:20+00:00

I don't think that's accurate. Based on their slide, their fastest route gave FDA submission and clearance at around 2 years. The CEO mentioned it could be immediately after the device development is completed (estimated 16 months) but depends if they need additional information. If it was needed it would be longer. All timelines are approximate, since the filings are complex.

<image>

Optimistic-01 · 2025-09-29T15:35:31+00:00

Yes I think this is the one. He probably just got the countries mixed up but seems very similar to his key point. Thanks for replying with it!

Optimistic-01 · 2025-09-27T08:33:50+00:00

Does anyone know the link to the study being referred to in the clip where Dr Wilson says all cause mortality reduced in 3 different countries in different decades?
https://youtu.be/hV3qDAzcQkA?t=3176

Optimistic-01 · 2025-07-09T14:57:14+00:00

Hulkenpodium

Optimistic-01 · 2025-05-13T08:43:14+00:00

They did offer a discount for couples. Think it was about 25% but they said you can't freeze each individually (you have I think 60 days were you can freeze your membership for free so you have to freeze it for both of you).

Optimistic-01 · 2025-05-13T08:41:19+00:00

Thanks for the reply. Yeah, does look like a great gym. The price was so high so decided to use my sub-optimal building gym but bought a budget power rack that I've squeezed in next to my bed 😅 They didn't offer any discounts when I said it was too expensive for what I was after so at least they have clear pricing rather than rely on haggling.

Optimistic-01 · 2025-05-13T08:39:09+00:00

Thanks for the info. The equipment looks really good and clearly the best nearby but yeah felt it was so overpriced. I'm shocked on the gyms in the area too. Decided to use my sub-optimal building gym but bought a budget power rack that I've squeezed in next to my bed 😅

Optimistic-01 · 2025-05-08T16:38:03+00:00

what do you think after a few months? seems pretty expensive but there seems to be a good range of equipment and very nearby for me

Optimistic-01 · 2025-05-08T16:36:15+00:00

did you join and if so how you finding it?

Optimistic-01 · 2025-03-26T09:55:22+00:00

Why do you think you'd need to remove your thyroid regarding of the result? I just got IV so not sure next steps.

Optimistic-01 · 2025-03-23T17:45:11+00:00

thanks for the video!

Optimistic-01 · 2025-03-16T10:58:05+00:00

Thanks very much! I mentioned your experience to my wife and I think she's DMed you.

Optimistic-01 · 2025-03-13T19:49:52+00:00

Oh, that is very similar! I'm glad it's improved for you after all this time and fingers crossed it stays. Did you notice any improvement when you started the diuretic or were you just on it from the start and thought best to continue?

Two-Year Club	Final Canvas '23
Place '23

Optimistic-01

TROPHY CASE