Tick. Tick. Tick. Tick.

Quote










































anonymous said:
Next the company will target the white older Christian males. D and I has got to get those numbers better. We need more color in the sales force.
Click to expand...


Remember, you all do yourselves a favor and NEVER sign a severance without consulting a good employment discrimination attorney.

My buddy got an "extra" 95K by paying an attorney 2K before signing.

The older you are (over 40 is the key age), and the more years you have in service, the better your severance will be and companies will always short change you on the severance, hoping you will sign with no attorney advisement.
 






anonymous said:
Remember, you all do yourselves a favor and NEVER sign a severance without consulting a good employment discrimination attorney.

My buddy got an "extra" 95K by paying an attorney 2K before signing.

The older you are (over 40 is the key age), and the more years you have in service, the better your severance will be and companies will always short change you on the severance, hoping you will sign with no attorney advisement.
Click to expand...

A severance or discrimination attorney is good in most cases. Just do it. You will thank me later.
 






anonymous said:
Sounds like fake news. What's your source?
Click to expand...

1. In January we started a bioequivalence study for a new formulation.
2. In July we started a Phase 1 trial looking at Hepatic impairment specifically.
3. In July we started a Phase 1 trial looking at Renal impairment specifically.

Phase 1 trials typically begin before Phase 3, not in the middle of Phase 3 registrational trials, unless something appears wrong during a safety review. It may be embarrassing for our R&D, and may draw serious scrutiny from the FDA into all safety issues. Did we try to rush the development of Fezo before we knew if it was safe?

Pass the word. And before you scream for proof, all 3 trials above are detailed on clinicaltrials.gov
 






The trials do check out on the government site.

They are short trials, which are designed to be completed before the two longer trials are finished. If safe, then no delays. If not safe, we may have long delays.

I do agree a mass restructuring is coming at the start of the Fiscal Year in 5 months.
 






anonymous said:
The trials do check out on the government site.

They are short trials, which are designed to be completed before the two longer trials are finished. If safe, then no delays. If not safe, we may have long delays.

I do agree a mass restructuring is coming at the start of the Fiscal Year in 5 months.
Click to expand...
A great place to start is in health systems. This is the easiest reduction because there is massive cronyism, so a lot of incompetence, and just plain ignorance, especially in the oncology landscape. Leadership needs to start digging around, look deeper, past the verboseness, and start recognizing there is zero accountability.
 






anonymous said:
1. In January we started a bioequivalence study for a new formulation.
2. In July we started a Phase 1 trial looking at Hepatic impairment specifically.
3. In July we started a Phase 1 trial looking at Renal impairment specifically.

Phase 1 trials typically begin before Phase 3, not in the middle of Phase 3 registrational trials, unless something appears wrong during a safety review. It may be embarrassing for our R&D, and may draw serious scrutiny from the FDA into all safety issues. Did we try to rush the development of Fezo before we knew if it was safe?

Pass the word. And before you scream for proof, all 3 trials above are detailed on clinicaltrials.gov
Click to expand...


Wow... So what if I told you that all 3 of these Phase 1 trials were planned long before we started Phase 3. It is very common to run Phase 1 studies alongside a Phase 3 registrational trial to address comments/questions from the FDA, examine a subpopulation (e.g. pre-existing conditions) of a interest, or generate evidence for specific language in the product label.

Do everyone here a favor and stop trolling about something you don't fully understand. We woudn't have started a Phase 3 unless we knew the drug was safe. No company would take that risk. Everything is on track, and you'll hear about it very soon.
 






anonymous said:
Wow... So what if I told you that all 3 of these Phase 1 trials were planned long before we started Phase 3. It is very common to run Phase 1 studies alongside a Phase 3 registrational trial to address comments/questions from the FDA, examine a subpopulation (e.g. pre-existing conditions) of a interest, or generate evidence for specific language in the product label.

Do everyone here a favor and stop trolling about something you don't fully understand. We woudn't have started a Phase 3 unless we knew the drug was safe. No company would take that risk. Everything is on track, and you'll hear about it very soon.
Click to expand...
 






anonymous said:
Wow... So what if I told you that all 3 of these Phase 1 trials were planned long before we started Phase 3. It is very common to run Phase 1 studies alongside a Phase 3 registrational trial to address comments/questions from the FDA, examine a subpopulation (e.g. pre-existing conditions) of a interest, or generate evidence for specific language in the product label.

Do everyone here a favor and stop trolling about something you don't fully understand. We woudn't have started a Phase 3 unless we knew the drug was safe. No company would take that risk. Everything is on track, and you'll hear about it very soon.
Click to expand...

I take it you no little about Phase 3. Phase 3 trials are designed to show efficacy and safety at a much larger scale. Many drugs have failed in Phase 3 due to unforeseen adverse events coming to light.

Similarly drugs have been pulled from the market due to safety issues coming out after approval.

Your ignorance is astounding about clinical trials show you drink the marketing kool-aid. Ask your MSL who is right.
 






anonymous said:
I take it you no little about Phase 3. Phase 3 trials are designed to show efficacy and safety at a much larger scale. Many drugs have failed in Phase 3 due to unforeseen adverse events coming to light.

Similarly drugs have been pulled from the market due to safety issues coming out after approval.

Your ignorance is astounding about clinical trials show you drink the marketing kool-aid. Ask your MSL who is right.
Click to expand...


Haha. Let me spend 5 minutes to educate you on how drug development works, because you clearly have no idea.

Most companies conduct some additional Phase 1 safety studies after Phase 2a (proof-of-concept, safety and efficacy on a small scale). This is done to save time and money, since most Phase 2a studies fail. You are the idiot who said that conducting Phase 1 studies during Phase 3 was a sign of safety problems. That is a lie.

Of course drugs can fail in Phase 3. They do about 30% of the time. But nobody would start a Phase 3 unless they thought the drug was safe based on Phase 1, 2a, and 2b data. This is true for all of our pipeline drugs. Phase 3 trials cost several hundred million dollars each, and we would never start Phase 3 without knowing a drug was safe. The Phase 1 studies we are currently running were planned long before we started Phase 3, plain and simple.

You really need to keep your mouth shut. You have no idea what you are talking about, and are only here to lie and make people nervous about their futures and jobs for no reason.

And FYI, I wouldn't trust what anyone in Marketing or Medical Affairs says about clinical trials either. Ask someone from Development about drug development. Ask Marketing about marketing, etc.
 






anonymous said:
Haha. Let me spend 5 minutes to educate you on how drug development works, because you clearly have no idea.

Most companies conduct some additional Phase 1 safety studies after Phase 2a (proof-of-concept, safety and efficacy on a small scale). This is done to save time and money, since most Phase 2a studies fail. You are the idiot who said that conducting Phase 1 studies during Phase 3 was a sign of safety problems. That is a lie.

Of course drugs can fail in Phase 3. They do about 30% of the time. But nobody would start a Phase 3 unless they thought the drug was safe based on Phase 1, 2a, and 2b data. This is true for all of our pipeline drugs. Phase 3 trials cost several hundred million dollars each, and we would never start Phase 3 without knowing a drug was safe. The Phase 1 studies we are currently running were planned long before we started Phase 3, plain and simple.

You really need to keep your mouth shut. You have no idea what you are talking about, and are only here to lie and make people nervous about their futures and jobs for no reason.

And FYI, I wouldn't trust what anyone in Marketing or Medical Affairs says about clinical trials either. Ask someone from Development about drug development. Ask Marketing about marketing, etc.
Click to expand...

The other poster had a point and exposed you. You claimed it wouldn't go to Phase 3 unless it was safe. Now you admit some fail due to safety. Which is it. Your anonymous integrity is trashed now. Seems you were lying in your first post and s/he got you to backtrack. You want to guarantee Fezo is 100% safe before it went to Phase 3? Yeah, I bet you won't.
 






anonymous said:
The other poster had a point and exposed you. You claimed it wouldn't go to Phase 3 unless it was safe. Now you admit some fail due to safety. Which is it. Your anonymous integrity is trashed now. Seems you were lying in your first post and s/he got you to backtrack. You want to guarantee Fezo is 100% safe before it went to Phase 3? Yeah, I bet you won't.
Click to expand...


"The other poster?" Haha, nice try. You don't understand nuance, so let me dumb it way, way down for you. Fezolinetant is a safe drug based on all available evidence. 100% of drugs that advance into Phase 3 are believed to be safe by the companies who pay for Phase 3. This applies to fezolinetant. Nobody would spend hundreds of millions of dollars on a drug they thought had safety problems. Again, fezolinetant is a safe drug based on everything we know.

Can we say any drug is 100% safe? Absolutely not. Sometimes we find safety problems in Phase 3, and sometimes it takes decades post-approval. About 17% of Phase 3 failures are due to safety problems. 57% of Phase 3 failures are due to efficacy, and others are due to a multitude of other reasons: Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review.

If you understand pharma, you would understand that safety is relative and constantly evolving. What we can say right now is that fezolinetant is a safe drug that has huge potential.

Let me put my Maury Povich hat on for a minute:
  1. On 10/16, you tried to claim that fezo had enrollment delays. THAT WAS A LIE.
  2. On 10/22, you changed your argument to saying fezo had safety problems because we are running some Phase 1 trials in parallel with Phase 3. This is common industry practice, and thus, THAT WAS A LIE.
Do you have anything of value to share? If you are going to troll people and spread lies, at least troll on a topic you understand. I can provide you with some lessons if you like. I won't even charge, I promise.
 






anonymous said:
"The other poster?" Haha, nice try. You don't understand nuance, so let me dumb it way, way down for you. Fezolinetant is a safe drug based on all available evidence. 100% of drugs that advance into Phase 3 are believed to be safe by the companies who pay for Phase 3. This applies to fezolinetant. Nobody would spend hundreds of millions of dollars on a drug they thought had safety problems. Again, fezolinetant is a safe drug based on everything we know.

Can we say any drug is 100% safe? Absolutely not. Sometimes we find safety problems in Phase 3, and sometimes it takes decades post-approval. About 17% of Phase 3 failures are due to safety problems. 57% of Phase 3 failures are due to efficacy, and others are due to a multitude of other reasons: Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review.

If you understand pharma, you would understand that safety is relative and constantly evolving. What we can say right now is that fezolinetant is a safe drug that has huge potential.

Let me put my Maury Povich hat on for a minute:
  1. On 10/16, you tried to claim that fezo had enrollment delays. THAT WAS A LIE.
  2. On 10/22, you changed your argument to saying fezo had safety problems because we are running some Phase 1 trials in parallel with Phase 3. This is common industry practice, and thus, THAT WAS A LIE.
Do you have anything of value to share? If you are going to troll people and spread lies, at least troll on a topic you understand. I can provide you with some lessons if you like. I won't even charge, I promise.
Click to expand...

Ouch. Take a valium dude, the guy is so far under your skin we're laughing at how mad you are.
 






anonymous said:
Ouch. Take a valium dude, the guy is so far under your skin we're laughing at how mad you are.
Click to expand...

Never. I do not feel bad for melting the poor snowflake. If anyone posts lies on here to make people worried, I will never hesitate to take them down. We all have a responsibility to call out liars.

If anyone has any serious questions about fezolinetant, I am happy to answer those. There is a lot of activity behind the scenes, and I think everyone is going to be impressed by the results and timeline.
 






Top Bottom
Back
Quote