Remdesivir Oral is being shelved for US

[anonymous]

Remdesivir Oral will be out in Europe 2023 but not US. After being stubborn with the FDA, Gilead will not move forward w US EUA application due to the FDA demanding to compare against Pfizer's Paxlovid in the trail. Gilead refuses because it will show only 35% efficacy vs Paxlovid 80% per medical insiders.
Executives will not give in on this design, nor will the FDA whom are Pfizer advocates.
Billions in the VKY oral will be made but not in the US.
Also Gilead ELT analyze competing against Pfizers few thousand reps selling Paxlovid & concluded could not compete with SOV or headcount to get even a small market share in US, especially with Paxlovid being established as the Gold Standard thar will be able to contract for Teir 1 pricing.... thus locking any small co oral agent out of the Commerical space --like Gilead.

 

[anonymous]

Disappointing as Remdesivir was the very 1st covid agent on the market including vaccines and should have been the first oral to the market !

 

[anonymous]

Jobs should be lost over this blunder!
Did Gilead have the same team on the VKY Oral that was responsible for Filog?
(btw that Galopogus is cruising internationally with now)

 

[anonymous]

Remdesivir Oral will be out in Europe 2023 but not US. After being stubborn with the FDA, Gilead will not move forward w US EUA application due to the FDA demanding to compare against Pfizer's Paxlovid in the trail. Gilead refuses because it will show only 35% efficacy vs Paxlovid 80% per medical insiders.
Executives will not give in on this design, nor will the FDA whom are Pfizer advocates.
Billions in the VKY oral will be made but not in the US.
Also Gilead ELT analyze competing against Pfizers few thousand reps selling Paxlovid & concluded could not compete with SOV or headcount to get even a small market share in US, especially with Paxlovid being established as the Gold Standard thar will be able to contract for Teir 1 pricing.... thus locking any small co oral agent out of the Commerical space --like Gilead.

Un-Fing-believable!
The entire HQ leadership team should be terminated !

 

[anonymous]

WTF.
I knew something was up with the Dead As Silent treatment the last few months in addition to our leadership avoiding questions and being evasive especially our ERD

 

[anonymous]

This is the 2nd Billion Dollar blunder in 24 months. Not surprising as Executives were not being aggressive to bringing the oral to market and seem to just want to be an Oncology company! How is that fiasco going .

 

[anonymous]

Well that's all I was waiting for- the oral.
Next month our measly retention is vested and we will be jumping ship enternally or externally faster than those jumping off the Titantic.

 

[anonymous]

Frustrating but given the leadership, I can not say that I am surprised. No wonder our new mgt evades the question and just wants us focused on hospital & not even Out Patient.

 

[anonymous]

Frustrating but given the leadership, I can not say that I am surprised. No wonder our new mgt evades the question and just wants us focused on hospital & not even Out Patient.

They seriously need to get the F off our backs then. Stop dragging us on metrics and call flow and coming out in the field w all of us. They know damn well this ship is getting ready to dock and yet they're all over us. WHY are we still hiring new people? Why do new people want to join this sinking ship? The only reason anyone is coming on board now is if they simply need a paycheck until the next gig. If you've got a decent job DO NOT come to Gilead to sell Veklury.

 

[anonymous]

Disappointing as Remdesivir was the very 1st covid agent on the market including vaccines and should have been the first oral to the market !

It's been quiet as a mouse and the reps suspected something wasn't good with the FDA. Well IV has 5yrs of LOE and that's enough time to land in a good place.
No need to panic.

 

[anonymous]

Paxlovid is killing it & HQ analysis likely determined could not compete with the beast!

 

[anonymous]

It's been quiet as a mouse and the reps suspected something wasn't good with the FDA. Well IV has 5yrs of LOE and that's enough time to land in a good place.
No need to panic.

Typical pharma-douchebag response. It's not about panic a-hole. It's about not dreading doing your job every day. While all you care about is getting a paycheck, some of us would like to feel like we're doing a a little more than that.

 

[anonymous]

Now makes sense with the top person in charge of bringing the oral to the market leaving Gilead after the most recent FDA meeting.... and our Covid RDs have not even mentioned or referenced her leaving. Kinda like they wanted to hide it from us reps.

 

[anonymous]

This is the reason Gilead is folding like a tent with the FDA Paxlovid demands.... unfortnately they already know the inferior results or they would already be doing trails.
If Gilead gave into the FDA Pax requirement, the results would not have allowed any intrusion of oral market share that Pax has generated but most important it likely would have undermined the few billion a year in hospital sales which Gilead is the only player.
Also likely the reason mgt only wants to discuss in-patient opportunity not OP.
Gilead is just playing the odds and keeping $2-3 Billion a year is better than loosing everything left holding nothing.
Plain simple business decision with the US market.
Internationally will be the oral play now

 

[anonymous]

This is the reason Gilead is folding like a tent with the FDA Paxlovid demands.... unfortnately they already know the inferior results or they would already be doing trails.
If Gilead gave into the FDA Pax requirement, the results would not have allowed any intrusion of oral market share that Pax has generated but most important it likely would have undermined the few billion a year in hospital sales which Gilead is the only player.
Also likely the reason mgt only wants to discuss in-patient opportunity not OP.
Gilead is just playing the odds and keeping $2-3 Billion a year is better than loosing everything left holding nothing.
Plain simple business decision with the US market.
Internationally will be the oral play now

Makes sense. Gilead was never really dedicated to this space anyway. They capitalized on a drug collecting dust on a shelf and made billions out of sheer luck. The oral hopes are over and I'm just hoping they'll give us advanced notice of a layoff like they did the group last year. At least it'd give us more time. I don't think anyone can really take much more of this can they?

 

[anonymous]

Makes sense. Gilead was never really dedicated to this space anyway. They capitalized on a drug collecting dust on a shelf and made billions out of sheer luck. The oral hopes are over and I'm just hoping they'll give us advanced notice of a layoff like they did the group last year. At least it'd give us more time. I don't think anyone can really take much more of this can they?

Time to move on from the incompetence & hidden agendas full of deception falsehood leadership.

 

[anonymous]

Time to move on from the incompetence & hidden agendas full of deception falsehood leadership.

The top person of the oral program leaving is not a positive sign.
At that level when a person suddenly leaves there is usually a difference in strategic vision.

 

[anonymous]

Well when NOBODY is talking about the oral in months at ANY level let alone CEO with Wall Street Analysts then you know it does not look good in the US.
If Dan ODay doesn't mention the oral program on next week's earnings call then it is absolutely over in the US.
(Must come out by Q2 2023 to even have a chance for 5% going against Paxlovid with a 1-2 year head start and 3,000 reps promoting it this Fall with a full promotional label.

 

[anonymous]

Maybe that's why Gilead has pulled back the oral knowing they can not compete with 3,000 reps and a company that has strong aggressive leadership who knows how to sell and market Billion dollar brands.
Dan might be just playing his odds of success, or more than likely just screwed up once again and drop the ball on the oral as VKY should have been the 1st oral to market if Dan would have taken covid serious like other big pharma companies did!

 

[anonymous]

Even when it does come out who wants to sell another me-too drug (pill none-the-less) that has one indication of COVID? If we would've been first, that's one thing but third now? Next Summer at BEST and probably not even then. Not to mention our hospital systems can't stand greedy Gilead. The way they've handled Remdesivir has been terrible.