Member Info for Transhaven

Example in full:

Examples

The FDA approved benzgalantamine (Zunveyl; Alpha Cognition Inc), a novel oral therapy, for the treatment of Alzheimer disease, on July 26, 2024. The manufacturer submitted the NDA on September 27, 2023, with an original PDUFA date of July 27, 2024—10 months from submission.

The length of time it is taking is getting more alarming now.

Google Search:

Key FDA Decision Timelines (Post-Submission)

Standard Review: 10 months (from acceptance of the application).

Priority Review: 6 months (for drugs that offer major advancements or fill an unmet need).

Initial Filing Review: 60 days (FDA determines if the application is complete).

Supplemental Indications: Median of 6 months.

Source: https://www.pharmacytimes.com/view/understanding-the-fda-approval-process-and-pdufa-dates#:~:text=Prior%20to%20the%20PDUFA%2C%20average,%2C%20on%20July%2026%2C%202024.

Examples

The FDA approved benzgalantamine (Zunveyl; Alpha Cognition Inc), a novel oral therapy, for the treatment of Alzheimer disease, on July 26, 2024.

🤣🤣🤣

Well looks like some interesting posts here today.

Email sent today and got a response back from the states an hour later when they were still asleep?

If the email is to believed it refers to staffing problems in Jan 2025, it is Feb 2026, no government department would be putting that kind of thing up as an Out of Office and also yeah it just is not right. It also talks of internal targets to an outside body - not going to happen.

So yeah - we just wait.

Maybe tomorrow.....

😂🤣 The PnDers have arrived - again.....

Bring yer mates Spod !

Have a nice weekend all.

#MaybeMonday

12th February sounds like a great day for an RNS!

My biggest investment is Microsoft..... so I really need some good news here. I even went all in on leveraged Microsoft so my losses are large but I am sure it will recover....

Fingers crossed that even if tomorrow does not happen we will get a result soon!

Who is going to join me at the 7am coffee club to ring in the RNS then? 😎🤩

Sorry that meant to read: No partners - YET.

Thanks Tonto. That also puts to bed the theory that partners would only be announced or come onboard after the FDA approval:

"The granting of ODD in the US will be helpful to any potential partner, but it is not a prerequisite and discussions continue" - so if they have got a partner for NXP002 then they can freely talk about it. Nothing stopping a company saying "If you get the FDA then yes we would partner" and in fact that could have strengthened the FDA application if (big if) there was something like having to prove the route to market but I doubt the FDA would be interested in that.

The point I am trying to make is that if there are any partners the companys can freely talk about that.

I make the point because some people have a narrative that we are waiting on FDA approval then all of sudden the partners will be revealed. There is no such need of a timeline like that and if there are partners they can be announced now.

As of now there has been no such announcement. So no partners.

One oh one looks like the winner was always chosen - star crossed double candle stick

ForFX I do not think anyone other than PIs have speculated that there are partners. No partner is going to touch this without federal approval.

I like to talk like I know what I am talking about but actually I do not know anything just like everyone else typing nonsense into here.

Have a nice day all.

I predict Feb 14th news bonanza !!!

Surprised that saying Spalding had a glory hole was allowed.....

Maybe......

That maybe the case Big_Kahuna but maybe ......

I have heard there is a glory hole in Spalding.

Maybe Friday.....

Maybe next month....

(If you are playing the "maybe" game please put "....." For added dramatic effect)

Gandernee Dude.... we are not on AIM. Basics.....

Maybe in the morning....

Thanks for the clarification Tonto and apologies for being rude earlier :)

Soup that was posted as the intention to keep staffing levels over the shut down, we do not know what staffing levels were actually in place in the FDA on shutdown or Christmas period which is what the original question was about.

So I stand by my posts and what I said.

There is no government department that will tell you their staffing levels especially a few weeks after the period you are talking about. The link you have provided is about something totally different it is about a contingency staffing plan in the event of a major event happening "In the event of a lapse of appropriation, 13,872 (86%) of FDA staff will be retained". It has zero to do with staffing levels over Christmas or any other period!

Also we are not invested in the US FDA it is NFX that we are invested in.

I suggest you stop posting utter c rap and cease your postings - or don't and continue to post misleading nonsense.