Any of the you guys have an opinion on MYMD-1. They have trial results coming out Q1 2022. Was looking into them for a long hold and planning to do a DD and writeup this weekend just wondering if anyone had come across is before/had any opinions
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Sounds like a pump and dump…
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I know these processes take a long ass time and that early stages do not a successful ticker make, but definitely worth keeping in back pocket as/if it reaches later stages I’d imagine.
I’ve been doing a lot of research behind the scenes on the best way to utilize the movements of clinical trials and the FDA. I am planning to do a full post seperate from this, but the basic conclusion im coming to is:
- approval plays (gambling on an approval) is generally a bad idea, and i dont think im going to be endorsing those without a really big reason in future.
- riding the general wave up from filing toward approval is relatively safe and this is more likely what we should be encouraging.
- biopharma has a lot of extra factors in it that cause a huge amount of uncertainty, and reducing that uncertainty(know what you are buying) or removing it all together are the keys to making more consistant plays.
So, with that being said, what the hell have i ACTUALLY been doing? Well, the short answer is: a ton of research on FDA holds. There is anreason im looking back at these right now, and it isnt just because PTGX was successful, but rather WHY PTGX was successful, let me explain:
The problems:
- FDA can put a trial on hold at any time and we wont know until it happens.
- Even without the FDA, prices tend to be pretty volitile, and can go tits up without the FDA’s help
- On approval there is no really good way to get a dependable pricepoint for a ticker to get to.
- Timing is fucking hard with pharma.
What holds offer that approvals dont:
- FDA already put the damn trial on hold, they could terminate, but that process generally takes a long time
- Working with companies that only have a few drugs in trials or even just one, and not much on the market limits oppertunity for price fuckery(see bluebird pharma for examples of fuckery)
- We start with a benchmark, we know what the price was, and after the hold, we know the hype was initially killed off, means we can set realistic expectations for movement.
- Timing is still difficult, but it’s much easier with holds because there is a process, and people are motivated to get shit back on track.
- (bonus) if you know how to read hold documentation and read trials for drugs, you can make a pretty good guess as to what will happen, even if when is trickier.
- (last bit of this list i promise) We have seen in recent cases (PTGX, ALLO) as well as several historical cases, (bluebird to some extent, and a small list of others that have fit my criteria) a few days after the initial dump, speculators begin to drive the price back up similar to an earnings play, meaning that cost of the longer term call positions can often be covered on those profits alone.
What does this mean? I think that FDA hold plays that meet certain criteria are similar to gamma squeezes, not that they ramp, but that they are predictable, and the upside is that generally, the market will have less effect on them due to it being a news pop, not TA/SPY related.
What I need help on:
I have searched a fair amount, and might just be an idiot, but there is no master list of drugs on FDA hold that I can find. Knowing what drugs are in a hold, is the first step in figuring out if they are worth investing in, and yes, i can comb the news, and that might be where we go with this, but to be able to make these plays we need to know they are happening, find good candidates in that list, and then QA those companies and drugs. This is where I could use everyones help, if we can begin creating that list, both currently held trials and trials that have had holds released or been terminated so we have more data to work with, I honestly think we can make a lot more money.
Thanks for reading another novel from me, feel free to post stuff for the list here in the short term, and I will talk to the admins about where it should go long term.
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Thanks, Pharma Bro!
Calls on FDA.
Probably should have gotten puts then.
To be fair, the FDA does what it wants, get an iron condor and blow up your whole account.
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Putting in that after midnight DD work babey
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You two are firsts in that club.
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Seeing a lot of buzz about NAUT and investments from AMZN. Anyone have any information regarding that?
Apparently AMZN invested heavily in NAUT, to the tune of 15mil in shares. That was highlighted on 05AUG21 and it saw a jump there. There was also a jump 2 days ago when twitter account biotechbreakouts seemed to pump it(tweet on 19OCT i believe). There have been a few reddit DDs as well, but most if not all the mentions there seem to be pumps.
I did a little more digging as well, and NAUT stuck its little head out of its shell only recently, the ticker started being tradable June 2021. There are currently no active clinical trials being performed by NAUT that i could find, and from the little i read, they havent been very forthright in what their goal is or how they will accomplish it…
That being said, it seems like its goal might be developing tech for the people developing drugs. I’ts small, 89 employees, located in seattle, and doesnt have a lot to show yet. So… barring anything new(potential reason for caution in the paragraph below) i’d say it is all sentiment right now.
I did see one thing in their description: “developed nautilus platform, a proteomics platform that includes end-to-end solution compromised of instruments, consumables, and software analysis.” It kinda feels… slightly sketchy? Might just have warning bells from theranos, idk. Proteomics is real at least, no idea who the competitors might be or what the rest looks like. Basically its all bunk or they could be the whole market for a segment of finding useful proteins for drugs, or anywhere in between, enjoy!
Interesting. I did some reading myself just now and the science seems legit, but I agree the company seems a bit shrouded. I looked through the investments of Bezos Expeditions and I’m seeing pretty consistently legitimate companies in the roster, so I would imagine their vetting is decent.
Not seeing any coming catalysts. Looks like their platform isn’t expected until late 2023 so any plays that would be off this would simply be sentiment and technicals (it’s currently looking like it’ll double bottom at it’s current price point.)
I appreciate the help 
No worries, I wont lie, biopharma is a very strange passion, i always enjoy finding new tickers. Sorry i couldnt dig into the science too much, been a very busy day in my personal life.
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Post this in the guide section would love to see a guide on how to research a pharma company the @Raiben way!
It’s interesting you say that, I’ve been working on exactly that all week, unfortunately i’ve had a lot of things happening outside of trades and the server, so it is taking me a little longer than originally planned. Hoping to have it finished come saturday night or sunday.
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There’s no rush can’t wait for the finished production if I can help please let me know!
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Will do, I think I gotta dig into some stuff with Navi and you to confirm (based on some historical cases) if what I’m finding on my own actually pans out overall, and so we can drill down on more specific indicators in the market tied to pharma stocks.
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Did some digging into upcoming fda decisions and pulled the following stocks that might have a decent chance at a run if approval is granted and nothing is fucked up.
BMRN – 11/20/21, If approved, Vosoritide would be the first drug for children with achondroplasia. , Blockbuster sales, according to analysts
AADI – 11/26/21, Priority Review, If approved, Fyarro will be the first FDA-approved therapy for the treatment of patients with perivascular epithelioid cell tumors (PEComa), Peak sales of over $2 billion by 2035, according to H.C. Wainwright & Co. analyst Robert Burns
BYSI – 11/30/21, Priority review, Blockbuster potential, according to analysts
CALT – 12/15/21, If approved, Nefecon would become the first therapy specifically designed and approved for the treatment of IgA nephropathy, Peak sales of $1 billion, according to analysts
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this is great info. thank you, kind poonisher.
I’m bullish on BYSI.
They have enough cash on-hand for the next 12 months, so dilution is unlikely. From their job listings, they appear to be gearing up for approval / production of Plinabulin.
The biggest risk is an FDA delay (similar to AVDL). I think 1/21 options would be safest if you’re looking to play options, OI is highest for that expiry as well. IV is also high right now.
Analysts currently have it as a “Strong Buy” with a PT of $63.
No positions yet, but it’s on my watchlist and I’ll likely buy shares and 1/21 options in the next week or so.
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BYSI - this drug is a first of its kind and long sought after for chemotherapy patients. It will assist in rebuilding the immune system after chemotherapy has been received. The blockbuster sales estimates are due to no available competition and basicly every single chemotherapy patient in the US being prescribed it. This is a highly risky gamble on if it actually works and if the fda actually approves it.