Author: buyersstrike

Twitter Jail – Update (TWTR)

Or not.

It has been 5 weeks and counting:

AppealRequest

Twitter censorship is 100% real.

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Quick Take – FDA delays Zogenix’s plan to poison children, sell side shill responds. (ZGNX)

Today after the bell, #fakeinnovation company Zogenix (ZGNX) announced that the FDA issued a “Refusal to File” letter for their recent NDA for “Fintepla“. This is absolutely the correct decision. Why?

Because Fintepla is not a new drug at all. It is #fakeinnovation. Fintepla is just a new brand name for a very dangerous drug that was taken off the market in 1997 for causing horrific heart valve problems in adults. That drug? Fenfluramine, aka Pondimin, aka the “Fen” in “Phen-Fen“.

Somehow the idiots at ZGNX thought 22 years later nobody would remember, and it would be a good idea to repurpose the drug and offer it to children. Guess not.

And the bigger idiots, of course, are the sycophantic sell side shills, like this moron, Danielle “Shill” Brill from Piper Jaffray.

ZGNXShill

After news like this she drops her price target from $72 all the way down to $68. As we say here at BuyersStrike! HQ, “hoes gots to eat too!”

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

 

 

 

Quick Take – When have you ever seen this? (THCT)

A company asking the SEC for permission to withdraw their registration statement, as it would not be in the public interest for investors to be able to purchase shares! Which leads to the question, what dark secret is the THC Therapeutics (THCT)Krim Krew trying to hide?

 

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

 

 

Quick Take – What’s in a name? (THCT)

Presenting just one aspect from the curious case of Vegas based, pink sheet stinker, THC Therapeutics (THCT), or is it Millenium Blockchain, or is it Millenial Weedscam? No matter what, it was, is and always will be a fairytale. As of today, the 5th of April 2019, a $220mm vape dream.

THCTNameChanges

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

 

 

A HAZY SHADE OF WINTER QUICK TAKE – PART 4 (TYME)

A few weeks ago we looked at the Tyme Technologies (TYME) “study “of their magic tyrosine cocktail, SM-88 (aka SMK, aka snake oil) in pancreatic cancer, catch up with that here.

Today, the jokers at TYME gave us all a little Valentine’s Day gift, interim “results” from their uncontrolled, open-label, tiny n, prostate cancer “study.”

One can find details on this terribly designed study, officially titled “Study of the Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate Cancer” here NCT02796898.

In today’s press release, the company declares: “TYME Reports Encouraging SM-88 Clinical Results”. In prostate cancer one easy metric is the patient’s PSA score. A declining PSA score is good. An increasing PSA score is bad. Says the company:

PSA levels generally remained stable during treatment.

That’s not actually encouraging at all. Now, here are the results that actually matter, from the poster.

TYME-PSA

Again “After 3 cycles of therapy (12 weeks), median PSA increased 40.2% from 6.4 to 9.0.” a 40% increase is NOT remaining stable.

FAIL.

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

A Hazy Shade of Winter – Part 3 (TYME)

Today’s the day. The day a filthy reverse merger bioturd called Tyme Technologies hosts a conference call to discuss the early results from it’s ongoing study of SM-88, a cocktail of 3 already approved drugs plus their magic Tyrosine.

We’ve already examined the birth of TYME, and its relationship to not one, but two, sanctioned lawyers and one moonlighting sell side shill, in Part 1, here. We’ve also looked at the four clinical trials testing SM-88, and learned that not a single one is truly legitimate. These “studies” have neither control arms nor double-blinding. Read more about them in Part 2, here.

Right now let’s look at the early data for the pancreatic cancer study, NCT03512756. It can be found in this abstract.

tyme-results

So, although the original study plan was for 115 participants, as of September 2018 the company had only managed to enroll 36.

Of these 36 subjects, only 83% (30/36) remained on treatment. What happened to the other 6?

Of the 30 that remained on treatment, only 16 were “evaluable” for CTC (Circulating Tumor Cell) blood testing. What happened to the other 14?

Of the 16 that received CTC tests, 11 showed reductions. Sounds impressive, but something is off about this. Nowhere in the clinical trial record does it actually mention CTCs as being an outcome measure! The only listed outcome measure of this study is Overall Response Rate using RECIST 1.1:

tyme-outcome

The abstract continues, mentioning that 2 of 9 subjects showed CA19.9 (a tumor marker for pancreatic cancer) declines. But CA19.9 is not an outcome measure. And where did this group of 9 patients come from? What happened to the others?

Less and less patients seem to be available as the abstract continues. Only 6 were eligible for the initial scheduled assessment. And 3 of 4 had what the company called “RECIST or PET SUV responses”.

What happened to the other 2 out of 6? And why the change from using only RECIST as the outcome measurement? PET SUV is not part of the study protocol. One can be sure that if the patients actually had a true RECIST response, PET SUV would never have been mentioned.

One can expect the scum behind this biodreck to hype these results, 3/4 = 75% ORR using their bucket shop math, but the real number, if one wanted to look at this data in the most favorable light possible is that only 3/36 patients had a measurable response.

36 patients enrolled

30 patients remained on treatment

16 patients were evaluable for CTC – Not a real, specified, outcome measure.

9 patients evaluable for CA19.9 – Not a real, specified, outcome measure.

6 patients made it to initial assessment

4 patients were actually evaluated

3 patients had a response using a non-standard criteria not in the clinical trial plan

3/36. That’s 8.3%. In an unblinded study. And even then, the study is so poorly designed it is impossible to tell which agent, or agents, had any activity.

Fail.

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.