Biostock-report
Some observations on recent events.
Consider viewing what you’ve been seeing within the following context.
A little over a year ago, a guy in China ate a bat. (Let’s just agree for argument’s sake and move on). A pandemic ensued. This affected every country on earth, naturally, and necessitated: lockdowns, social distancing, masks/ppe, job furloughs, lots of cancellations, loss of businesses/jobs/income, and more. (You were there!) This is one year and counting.
Due to the severity of the virus and need for intensive treatments and hospital stays and doctor visits, health care could not be denied. This presented an urgent and dire situation and inaction would have spread the virus further and faster.
The multitude of emergency hospital stays could not be billed for and insurance carriers and or government had to foot the bill.
Many workers were furloughed and could not pay their regular healthcare insurance premiums due to no income. Payment to insurance companies had to be deferred - government supplemented money with stimulus checks but not nearly enough.
A guy in China ate a bat and our insurance sector is now facing an imminent crisis. Not nearly enough money coming in to offset the requirements to continue paying for all of the regular chronic care illnesses and an unexpected pandemic on top.
BaltimoreBullet: I agree that the insurance sector is synonymous with “safe as houses/can’t fail”, but the housing market actually DID FAIL not that long ago. You are right that they bring in much more than they pay out. Not this year. Not with a half a million people dead from covid and millions (hundreds of) out of work. Black swan.
Insurance crisis would affect every person going forward - we can’t let them fail, same as houses.
The government(s), all in the same boat worldwide, can’t support everyone in their country with no taxes.
A guy in China ate a bat and it set this in motion a year later: the insurance sector is on the verge of collapse.
The time has come for the governments of the world to find treatments for diseases which had long been covered by insurance carriers with no hope of being treated or cured. Also, nursing homes can no longer be afforded for these people as is often necessary.
The FDA had to decide that it was time to get the cures out and stop warehousing the chronically ill, untreatable. I believe they asked Biogen to submit the BLA as a means of rescue from the burden of AD. The game had always been that BP could come up with something and FDA would bless it. (FYI - No! There is NO collusion or cabal, yada yada...I like to play devil’s advocate with myself when I know I’m just imagining things - just ignore notes to self.)
The FDA realized after reviewing Biogen’s candidate that it would not solve the problem and probably cost even more in hospital stays for infusions, and brain swellings. I did some DD and if anyone ever finds themself in Hell after this life, the WiFi password is “Aducanumab”. They have great encryption there but are easily bribed:)
In Heaven - no password - unrestricted WiFi.
At about the time FDA realized Aducanumab would not help, they found other biotechs with drugs which actually COULD help in this situation and avoid crisis.
Problem: all of these companies were small biotech rivals of BP and had been starved and suppressed for years. (Starting to get the picture?)
(No one is being starved etc...yes, that picture...)
Meanwhile, a renegade group of pandemic bound 20-somethings, who had been locked down and gaming for a year and zero money, received some stimulus checks. They all had Robinhood accounts. They had been trading for S&G’s with little experience and little money. Recently, they found out that their favorite pastime, gaming supplied by GameStop, would not be giving the adequate dopamine hit because GameStop was not able to release new games as their stock had been shorted rather criminally.
The young, home bound, bored, rebellious kids with no money and no games, hooked up on social media and decided to wage a bloodless coup of WS. And they won!
They bought GameStop and cinema stock because that is their demographic. Period. End of story.
Until...FDA, insurance companies, media, government (SEC) realized they could solve the insurance crisis which could not be publicized. Under cover of Reddit WSBets raiders - just out for a good time, ahem, they decided to pivot to “liberating” exactly 4 biotech companies with promising AD drugs.
A guy in China ate a bat and my kids (21 years old on social media, gamers, robinhooders) who care about my generation and my parents’ generation enough that they don’t even return my car with any gas left in it (EVER!), suddenly decide to raid 4 insanely shorted promising biotech companies.
(Still laughing...)
The media does what they do best: they cover the story and blitz it on Business channels (which investors watch - not Main Street). They publicize the 4 biotech companies and state that they are Reddit targets because they are “undervalued, promising” companies.
Famous quote: There’s no such thing as bad publicity, except an obituary.
We get exposure. Step one. Our stock shoots up (an upward correction, not revenge or irresponsibility). Step Two. This is how the stage plays out.
The Amyloid theory is being booed, new approaches are being “discovered” and the companies are being introduced and revalued to make sure they fit the script.
Wall Street shorts are told to back off, hedge funds jump in. The FDA will bless 2-3 drugs in this space after relatively little deliberation - fast track all!
They step on you, until they need you. They need us.
This is not a mystery - it’s obvious. Robin Hood accounts can’t trade after hours and certain tickers. The kids could not care less.
Anavex has been weighed and found extremely necessary to the failing economy - worldwide. As has Cassava. We need to go through the transition to be acceptable as the real deal - our stock price will become legitimate because it HAS to. They NEED us. Btw, our stock price was supposed to be valued much higher all along. See what happens when you are not the disruptor but the fixer?
Expect to hear our name on tv and see it in print and a media blitz/Ted Talk about new approaches to AD.
No more trolls or shorts of the Twitter variety.
And things go quietly about their business and we succeed in an arena much sooner than expected because a guy in China...
Sounds like a great story.
Please consider:
We will need 2 large, long, costly AD trials with sufficient diversity. I’m not a medical doctor, however, my reading and comprehension skills understand that the FDA is currently reviewing THIS from Biogen.
Meet: EMBARK (the only data now being reviewed for the Jun 7 decision)
It’s fewer than 200 patients, 24 weeks max - not all - began the ole in Mar 2020 and submitted data in Jan 21, so, single arm! I kid you not. Look it up, please.
The FDA is desperate because they and media got hopes up for AD folks so they must approve something. Also, did I mention insurance is broke? They continue to search - LLY has a chance, BIIB, but now, the pivot to 4 rising stars has the earmarkings of a new regime.
Funny, that Biogen’s stock is not skyrocketing in anticipation of an imminent approval of the holy grail drug. But, 4 other tickers who languished for years are. That’s astounding!
(No. Just no.)
The key is that the drug must work, so now it’s a jump ball. (Devil’s advocate: there’s no jump ball. It’s just the FDA trying to do things properly and same with the companies - who have each risen by several fold in price and gained major attention with no explanation - other than that this is SAVA’s ph2 interim results wave riding.)
SAVA, it should be noted, is a one trick pony - AD. Works a little further downstream to clean out the toxic debris from the plaque, according to Falconer. The company has received funding from the NIH thus avoiding dilution and has a lower float but higher short than AVXL.
AVXL has very promising results from Blarcamesine for Rett (Randi Hagerman, MD), and PDD ph2 success. Our biomarker has been proven in 3 different CNS diseases in clinical trials along with the MoA and we see increasing preclinical evidence of same. (I have entirely new DD on cancer which I will post. Cancer and CNS and covid-type viruses also...tic, tac, toe).
The real circumstance which puts AVXL ahead of SAVA for approval aside from overall usefulness (although I do not view this as a pissing contest - 2 AD drugs which work would be great!), is that we are holding pocket aces in AU. (No, this isn’t some magical game of poker...it’s a biotech company which may prove out in 4-5 years after many trials!)
Full disclosure: I recently bought a parrot and taught it to say, “No one is trying to steal your shares. Cheap!” all day long so I keep that in mind.Lot of pandemic downtime.)
Our pocket aces are that we enrolled our AD trial in AU beginning July 31, 2018. July 2020, all had completed the trial and we had ended enrolling in AU at 50% of 450 n and began recruiting worldwide.
Therefore, we are sitting on 225 completed trialed 3 arm blinded controlled participants in AU, where we have already received SAS for the drug and indication from an earlier trial and extension.
When asked if we intend to do an interim analysis of the AD folks, Dr M says we can but don’t have to - evades the question. Why? Because there’s a play under review on the field as to the spot. (Except, There’s no review on any field and nothing magical...)
We don’t know if we have first down or need the punting unit - depends on the “spot” and that happens Jun 7.
If BIIB is turned down, we can let the clock run (there’s no clock) with fresh set of downs. First and goal. Or, if BIIB is approved (or anyone else for that matter), we do the interim and get the Aussie approval with MORE DATA and better results than either other drug approved. Then, the fans will dump the Gatorade and demand a trophy for us - US, FDA. (No gatorade and no trophy for you - one year. -The reality police.)
Also, the new sites will be Ph4 as many have posted.
All because a guy in China...
You should decide whether or not to sell, buy, hold within your view of this untrue connection of dots.
But, recall, it takes a battleship a little while to turn around. That is what appears to be happening - we are: gaining share price and media attention after 6 years on no news and no catalysts and the insurance sector is drowning and the govt can bail them out and old folks in Australia are driving again after having their licenses revoked due to dementia.
(Minus the nonexistent battleship)
But, if there WERE a battleship turning, it might go something like this (although I’m sure it’s not):
The shorts cover and our price lifts and they assign that to Reddit. Check. Then, shorters reshort at higher and higher prices and cover lower for their position but higher each time...to slowly let the pressure off but grow the price. This makes up for us never having IPO’d - so, everyone can cover in steps and make several big sized gains while hedge funds also come in. It’s an All Play. (It is not!)
Shout out to Black Rock for getting in early - that’s what you get for not playing with your head up your axx. - Paul Newman, The Sting, poker scene
That about sums it up. GLTA, remain safe. Dispose of your chips how you chose -
(No magical chips. But...they are!)
Lots of really fantastic posts all through by everyone - thanks a
M-I-L-L-I-O-N... !
Biostock
