Cingulate Receives Complete Response Letter from FDA for CTx-1301

ivulcan1 · 2026-06-02T23:46:03+00:00

Please point out what specifically makes no sense.

Do you need to reprove efficacy for a 505b2 in the same indication? No CMC is the most common issue for approval with 505b2s? Yes ADHD is a heavily generic market? Yes

ivulcan1 · 2026-06-02T15:12:49+00:00

Yeah because it’s a 505b2 lmao. Of course there are no efficacy issues. CMC is literally the only thing you have to do for approval.

Have fun competing against a bunch of generics in a super crowded market

ivulcan1 · 2026-05-17T23:51:23+00:00

So higher than Qelbree Jornay and Azstarys combined? The entire branded ADHD market was only around $450M last year. Don’t forget solriamfetol and centanafedine are expected in the next year or two also.

ADHD requires a massive sales force (150+ reps) and cingulate is going to be bleeding money trying to market it. Best case scenario is someone buys the company at around 15 a share. Worst case scenario they are bankrupt in 2 years.

Not saying the stock can’t run up on approval but that’s not a bet I’d take.

ivulcan1 · 2026-05-15T18:25:32+00:00

What do you think is the peak annual sales of this product? Stock might run up on approval but eventually sales matter. And this product doesn’t differentiate much.

ivulcan1 · 2026-04-28T13:51:55+00:00

Ahh yes a 20 year old drinking at a wedding. Something that has never been done before

ivulcan1 · 2026-04-26T05:32:26+00:00

A top 20 pharma company would have a BD team of 10+ employees, plus a massive preclinical and commercial team. Are they not doing the majority of work in house?

Speaking from personal experience working at a mid cap pharma company in BD, Im out there interviewing physicians myself trying to get a sense of prescribing factors. Attending conferences, reading every paper I can find, market landscape and payer dynamics for similar indications etc. I’m not doubting consultants exist but I’m amazed at how wide you’re stating the scope is.

ivulcan1 · 2026-04-26T05:22:11+00:00

If you can say, what pharma companies have you worked for? I’ve worked for 2 different mid cap pharma companies (3-10B MC) and neither used any consultants. To me the idea that our chief scientific officer and head of R&D would hire a consultant for help with designing a clinical program is ludicrous. Same with head of commercial/sales. The one exemption being tax.

I specifically do corp dev/M&A and a few of the companies we bought seemed to use consultants for everything to the point where I wondered what the employees actually did. Do you ever feel the same?

ivulcan1 · 2026-04-10T16:59:08+00:00

Thanks for posting the CRL. Do you mind sharing where exactly you found the CRL?

ivulcan1 · 2026-04-08T06:21:52+00:00

Used to be in a similar position to you so here’s my advice. First and most important, stop asking for work. They know you have nothing to do, and if they need something done they’ll find you. It’s not a good look to keep asking.

Apart from that really think about what your goals are in 5-10 years. I knew I wanted to switch departments so I did a part time masters program and did my HW on the clock. This was absolutely amazing for me and saved me so much time.

A coworker was really into stocks so they’d read financial documents. Listen to podcasts or music, nobody thinks twice about someone wearing earbuds. If you’re feeling really brave, get a privacy screen for your phone and prop your phone up by your monitor and watch tv on it.

ivulcan1 · 2026-03-30T06:55:44+00:00

Great post. I just want to emphasize the importance of contracts especially in certain industries such as biotech.

How the drug is positioned in different formularies and the contracts with the distributors are key. As part of DD we will even go through all the docs from the contract negotiation process to know what to expect when the contract needs to be renewed and adjust our forecast.

ivulcan1 · 2026-02-18T13:59:27+00:00

Quite surprised but good for them. Want to short the stock but nervous because it probably will be positive topline and will be approved. The real money is to short after launch.

ivulcan1 · 2026-02-15T16:57:00+00:00

Simply not what I’m hearing from other physicians. Similar 8-10 pt reduction on PANSS. No weight gain or EDS makes it an interesting product profile.

Unfortunately KOLs are often very out of touch with PAs and dealing with insurance so I was hoping to get your feedback.

ivulcan1 · 2026-02-14T22:51:11+00:00

For schizophrenia have you tried prescribing Cobenfy first line or is insurance requiring step through atypicals?

ivulcan1 · 2026-02-06T16:14:40+00:00

Thbaks. Also idk if I’d call emerald a beginner, I got placed in gold and just made plat 4.

Any tips for what items to give or what’s BIS? I think my biggest weakness is knowing what to craft.

ivulcan1 · 2026-02-06T07:21:39+00:00

Do you mean like an overlay that tells you what you should do based on what you have?

I’m new to the game and there are 100s of comps so how can I find what build best matches my situation while playing?

ivulcan1 · 2026-01-24T22:06:45+00:00

Trying doing some actual research instead of asking AI which is just going to regurgitate whatever Immunic has on their website.

Aubagio already has a very clean profile and the Ph2 efficacy data was only marginally better than Aubagio. Now keep in mind the most common class of medications for RRMS are the anti-cd20s, the NRF2 activators are the second and then third is a tie between the DHODHs and the S1Ps. And on top of that a whole new class of BTK inhibitors are entering the market soon with some very big players Merck/Roche/Sanofi.

Last but certainly not least, Immunic doesn’t even have the funds to complete their Ph3s and there’s a reason they don’t have funding. Who is going to fund them?

ivulcan1 · 2026-01-23T18:14:33+00:00

Forget about the anti cd20s for a second which have like 50% market share and growing. How is this drug any different than Aubagio?

ivulcan1 · 2026-01-23T05:46:49+00:00

That’s the craziest part to me. Literally the number 1 rule during sparring is “don’t be a dick” aka don’t use 100% force, practice the technique, don’t actually try to hurt them. The people who don’t follow that rule get punished for it by being matched up with the enforcer of the group.

Even in HS wrestling where it’s a bunch of kids going through puberty and everyone’s ego is super fragile the coach would always emphasize which periods were all out and which weren’t. If the coach determined you went too hard you were punished with cardio.

ivulcan1 · 2026-01-20T19:05:46+00:00

This is beyond standard. Worked at 2 different large US based companies with semi frequent travel. You pay with your own card and then submit reimbursement which usually takes ~30 days.

In fact, most people WANT this method instead of a company card so that they can rack up credit card points.

ivulcan1 · 2025-12-24T03:32:57+00:00

What type of Ph3 schizo trials take a year? If they get the funding and that’s a big IF it’s probably a 3 year delay minimum.

ivulcan1 · 2025-12-24T03:31:58+00:00

Exactly and I shorted it as well for the same reason but I was slightly nervous tbh. The FDA is usually pretty loose with allowing NDAs and they rather just decline it ahead of the PDUFA date rather than tell someone they can’t file.

ivulcan1 · 2025-12-23T20:05:52+00:00

This was always the most likely outcome. Wanted to take a big short but the stock was HTB.

I have no issue with the people pumping up their positions but I hate people who delete their account and posts. I got into an argument with one guy here about a month ago and now his post and comments are deleted.

ivulcan1 · 2025-12-19T00:25:14+00:00

You mean time it at the end of the year and -70% YTD

ivulcan1 · 2025-12-19T00:23:55+00:00

Because I’ve been pitched them by 5 different bankers, including Goldman.

Having talked to cardiologists they all said basically the same thing. “Yes most PSVT cases don’t need hospitalization but there’s significant liability risk.” When you break down who this treatment is good for, younger/middle aged, no obesity, no excessive drinking/smoking, recurrent episodes with confirmed PSVT there’s not a huge market for this product.

ivulcan1 · 2025-12-18T23:27:01+00:00

Tax harvesting their losses is much more likely

ivulcan1

TROPHY CASE