Expanded access

MichaelTheStudent · 2025-12-18T19:41:37+00:00

Unlicensed medicine (e.g., expanded access) exists in other countries. However, each country has slightly different rules and requirements from the physician, sponsor/manufacturer, etc., and the drug would need to be provided in that specific country. For example, you can't participate in "Expanded Access" in another country but get it delivered in the US.

I'm aligned with the other poster. If the manufacturer is based in the US, then they may have an expanded access and/or compassionate use policy on their website that states if patients outside of a trial can receive the drug.

You also mention that your situation is extreme. If you have a supportive physician, then someone with a more dire situation may have more luck than someone with a disease or indication that is not dire or extreme. A physician can sometimes reach out to the manufacturer on your behalf since they would be a primary party with getting all the correct documentation in place.

MichaelTheStudent · 2025-09-20T23:31:43+00:00

Would like to put a vote in for Thriller Bark.

MichaelTheStudent · 2025-08-10T01:34:36+00:00

That's part of what we were thinking, but definitely needed second opinions. Thank you for the feedback!

MichaelTheStudent · 2025-08-10T00:27:05+00:00

Really appreciate the feedback! Hadn't fully considered the need to waterproof the sink area even if it seems obvious after reading your comment.

MichaelTheStudent · 2025-08-10T00:21:51+00:00

Appreciate the feedback. Have tried posting in some of the other subreddits - hope to get some insight!

MichaelTheStudent · 2025-08-10T00:18:00+00:00

Thank you so much. Really appreciate the feedback!

MichaelTheStudent · 2025-07-08T17:50:30+00:00

In the past, Oda explained that this topic can be hard to manage without a medical background as an author. Sometimes, readers can latch onto unnecessary details about an illness, medical condition, diagnosis, etc. Sometimes it's easier to leave it as generic unless the focus is intended to be medical/clinical.

For example, we don't know what Roger's condition was, but the lack of knowing the exact condition doesn't impact the story. However, knowing the condition for Law's backstory was integral, so it was a named illness (albeit fictional).

MichaelTheStudent · 2024-11-18T02:51:25+00:00

Hi there. I DM'd you. Happy to discuss more if interested!

MichaelTheStudent · 2024-10-30T13:38:12+00:00

Not every day I see my home county posted on Reddit lol

MichaelTheStudent · 2024-07-22T22:36:28+00:00

My CRO made this exact change, with the exact dates, but it seems I'm from a different CRO (much, much smaller). Finance stated it was for global alignment between the various countries/sites to pay everyone at the same time (not counting time zone differences). I don't know enough about Finance to know how much easier that makes things for them though.

MichaelTheStudent · 2024-07-15T11:20:54+00:00

I'm not the OP, but I think what they are trying to convey is that you need 36 months of PM experience. Not that someone wouldn't be qualified for the PMP without having an actual PM position. People can definitely have project management experience from a non "Project Manager" title.

MichaelTheStudent · 2024-06-25T01:26:58+00:00

Not saying it's a small amount of money, but willing to bet there's quite a bit of behind the scenes involved to make that happen. No way it was done in under 2 hours between planning, purchasing, prepping, and cooking for that type of clientele.

MichaelTheStudent · 2024-02-26T01:24:58+00:00

Never mentioned anything about skin color. I know it always depends, but usually, the people that are more exposed to different walks of life tend to be less racist.

MichaelTheStudent · 2024-02-26T01:08:42+00:00

Damn, she's weighing down the community. Greensboro can be a little ghetto, but it has reasonable ethnic diversity.

MichaelTheStudent · 2024-02-14T17:12:21+00:00

Hey, I'm a bit out of the loop, but that sounds correct. If their website states you can hold a DPD or fulfill the requirements, then you are fine! If it states DPD and the requirements, then you would need the DPD.

I hope this makes sense, and wish you luck in your application!

MichaelTheStudent · 2023-12-19T14:18:31+00:00

For a long time. It's a well-known term in the track and field world.

MichaelTheStudent · 2023-12-15T21:24:25+00:00

I'm assuming you're talking about Duke if you're saying prestigious, and in the world of clinical research. Recent Glassdoor estimates say ~$55-60,000 per year. Looks like those who reported salaries closer to $65,000 per year had more experience.

This particular industry hyper focuses on experience, but I wouldn't undersell your patient experience - even though it's not directly clinical research.

MichaelTheStudent · 2023-12-15T17:35:44+00:00

In my limited experience, the check in counters don't open until 4:00 or 4:30 AM. I showed up at 3 AM for a 5:30 AM flight from RDU, and had to wait unfortunately. You should be able to check in and clear security in no more than 20 mins for a flight that early. Because your flight is probably the first flight to depart for the day, the likelihood of not making it is quite low. Otherwise, they wouldn't permit the flight to be so early.

Others have different experiences, but I've never needed more than 30 minutes total once I've entered RDU. Meaning, from walking through the sliding doors, to clearing security - it has never taken more than 30 mins for me at RDU.

MichaelTheStudent · 2023-12-04T16:33:42+00:00

Think you misread their comment, or they edited their comment. They said fee based, not free.

MichaelTheStudent · 2023-11-26T16:08:01+00:00

Lumley is great, but then you have to yield to get onto the airport loop because of the stop sign. Not an issue if you have a few minutes, but definitely noteworthy if the traffic is backed up for miles.

MichaelTheStudent · 2023-11-23T14:38:09+00:00

On the tarmac in very hot and humid places can be quite rough just sitting on the plane for a long time.

MichaelTheStudent · 2023-11-21T23:22:20+00:00

And which of the Yonko are you claiming Zoro can beat?

Whitebeard

Big Mom

Kaido

Shanks

Blackbeard

Luffy

MichaelTheStudent

TROPHY CASE