Pfizer contract

[Anonymous]

I'll be watching carefully because I am counting on this job. I can't go much longer with no income and no insurance. If this falls through I have no other interviews coming up and am pretty bummed. I have applied for probably at least 10 other jobs just in the last 2 weeks, but notihng, after an AZ phone screen, there is just dead silence.

Have you been offered the job contingent on approval? If not and the drug is approved you may still have a hurdle to cross with another person interviewing for final

 

[Anonymous]

Have you been offered the job contingent on approval? If not and the drug is approved you may still have a hurdle to cross with another person interviewing for final

It is unlikely this drug will be approved on Tue. Check the news on Tue. If you reaaly want this contract job you will be waiting a looong time.

 

[Anonymous]

It is unlikely this drug will be approved on Tue. Check the news on Tue. If you reaaly want this contract job you will be waiting a looong time.

Reading some article on fiercebiotech date is shown as the 23rd. So if no news on 21st then wait till 23rd.
I will be surprised if it is approved next week. I think 3-6 months and if that is the case they will start recruiting all over again

 

[Anonymous]

Reading some article on fiercebiotech date is shown as the 23rd. So if no news on 21st then wait till 23rd.
I will be surprised if it is approved next week. I think 3-6 months and if that is the case they will start recruiting all over again

THEY'RE ONLY GOING TO START RECRUITING ALL OVER FOR THE TERRITORIES WHERE A REP ISN'T AVAILABLE,THEY'RE NOT GOING TO THROW GOOD REPS BY THE WAYSIDE. AND IF YOU LOOKED AT THE NEWS IT LOOKS LIKE PFIZER WILL GO FOR A UC INDICATION DOWN THE ROAD.THE FDA HAS BEEN SLOWER TO APPROVE NEW DRUGS DUE TO LIABILITY THIS DRUG COULD BE BIG.

 

[Anonymous]

Reading some article on fiercebiotech date is shown as the 23rd. So if no news on 21st then wait till 23rd.
I will be surprised if it is approved next week. I think 3-6 months and if that is the case they will start recruiting all over again

Fierce sent out a correction on that. It's August 21 and it's not vonna get approved. I guess you are only wasting 3 more days by holding out hope on this:

http://www.businessweek.com/ap/2012-07-31/pfizer-study-arthritis-pill-beats-standard-drug

 

[Anonymous]

THEY'RE ONLY GOING TO START RECRUITING ALL OVER FOR THE TERRITORIES WHERE A REP ISN'T AVAILABLE,THEY'RE NOT GOING TO THROW GOOD REPS BY THE WAYSIDE. AND IF YOU LOOKED AT THE NEWS IT LOOKS LIKE PFIZER WILL GO FOR A UC INDICATION DOWN THE ROAD.THE FDA HAS BEEN SLOWER TO APPROVE NEW DRUGS DUE TO LIABILITY THIS DRUG COULD BE BIG.

Don't kid yourself. If this drug is delayed more than a few months there won't be many still waiting around. 6 months they will start recruiting all over

 

[Anonymous]

Fierce sent out a correction on that. It's August 21 and it's not vonna get approved. I guess you are only wasting 3 more days by holding out hope on this:

http://www.businessweek.com/ap/2012-07-31/pfizer-study-arthritis-pill-beats-standard-drug

Yeah really - and now it's 2 more days til Tuesday. There is a < 1% chance of the drug getting approved on the PUDFA with a p value =.00000019

 

[Anonymous]

THEY'RE ONLY GOING TO START RECRUITING ALL OVER FOR THE TERRITORIES WHERE A REP ISN'T AVAILABLE,THEY'RE NOT GOING TO THROW GOOD REPS BY THE WAYSIDE. AND IF YOU LOOKED AT THE NEWS IT LOOKS LIKE PFIZER WILL GO FOR A UC INDICATION DOWN THE ROAD.THE FDA HAS BEEN SLOWER TO APPROVE NEW DRUGS DUE TO LIABILITY THIS DRUG COULD BE BIG.

The UC indication is at least 2 years away. They have to do a full scale trial.
Yes this drug probably will hit the marks down the road but it will be several years at best.
The RA indication will probably be 2nd or 3rd line trials.

DON'T HOLD YOUR BREATH....MOVE ON WHILE YOU STILL HAVE A SHOT

 

[Anonymous]

This drug will be approved for RA and will be huge. It may not be Tuesday. The panel voted 8-2 from the info they saw. People posting that it is a dud have not researched the info that is public knowledge. FDA is just covering all the bases. Can you blame them?

 

[Anonymous]

This drug will be approved for RA and will be huge. It may not be Tuesday. The panel voted 8-2 from the info they saw. People posting that it is a dud have not researched the info that is public knowledge. FDA is just covering all the bases. Can you blame them?

I will keep believing until told otherwise that the FDA will take the panel's recommendation and pass it. This is so novel, something that is not an injectible for RA. It will be a blockbuster and I will get the position. I am confident.

 

[Anonymous]

I interviewed for a position with a company I will not name for a position that was for a new drug waiting for approval the interview was in may 2009. They said they were certain the FDA would approve it in June as it was the second round of trying to get approved. The end of June it was denied.. So all the interviews and stress and nobody got the job.dont hold on to something that may not happen and an approval could take another 9 or more months.

 

[Anonymous]

This drug will be approved for RA and will be huge. It may not be Tuesday. The panel voted 8-2 from the info they saw. People posting that it is a dud have not researched the info that is public knowledge. FDA is just covering all the bases. Can you blame them?

Drug no doubt will get approved one day......just won't be next week.
My guess is 6-12 months. I have seen this with a few others and it was about 9 months wait time. Good luck if you want to wait, who knows maybe they will extend the contract past 17 months

 

[Anonymous]

Drug no doubt will get approved one day......just won't be next week.
My guess is 6-12 months. I have seen this with a few others and it was about 9 months wait time. Good luck if you want to wait, who knows maybe they will extend the contract past 17 months

Some of us have no other options, some of us have been out if work a long time

 

[Anonymous]

Some of us have no other options, some of us have been out if work a long time

So you are going to sit and wait for something that may not happen for 1 year?
I understand you waiting till this week but if the drug doesn't get approved you need to go look for something else my friend.

 

[Anonymous]

So you are going to sit and wait for something that may not happen for 1 year?
I understand you waiting till this week but if the drug doesn't get approved you need to go look for something else my friend.

Yeah really. These guys don't get how it all works. Read this about the additional data and tell me you still think it gets approved Tue

http://www.thepharmaletter.com/file...rs-tofacitinib-possible-regulatory-delay.html

 

[Anonymous]

FDA requires additional analysis

Additionally, Pfizer noted during its second quarter earnings call (see separate story today) that the US Food and Drug Administration has recently requested additional analysis of the existing data in the tofacitinib New Drug Application. Pfizer said it is planning to provide the agency with this information in early August and, given this timing, it anticipates that FDA may require additional time beyond the August 21 Prescription Drug User Fee Act (PDUFA) date to review the information.

The FDA’s Arthritis Advisory Committee recently voted eight to two to recommend approval of tofacitinib for the treatment of adult patients with moderately to severely active RA (the Pharma Letter May 10). The FDA advisors also voted seven to two that the drug was safe, and unanimously (10-0) that it was effective.

 

[Anonymous]

FDA requires additional analysis

Additionally, Pfizer noted during its second quarter earnings call (see separate story today) that the US Food and Drug Administration has recently requested additional analysis of the existing data in the tofacitinib New Drug Application. Pfizer said it is planning to provide the agency with this information in early August and, given this timing, it anticipates that FDA may require additional time beyond the August 21 Prescription Drug User Fee Act (PDUFA) date to review the information.

The FDA’s Arthritis Advisory Committee recently voted eight to two to recommend approval of tofacitinib for the treatment of adult patients with moderately to severely active RA (the Pharma Letter May 10). The FDA advisors also voted seven to two that the drug was safe, and unanimously (10-0) that it was effective.

additional analysis of the existing data
Which tells me 3 months tops. Not new data just a different analysis of existing data. If you read it the panel voted in favor of pre-approval. This is the facts.

 

[Anonymous]

additional analysis of the existing data
Which tells me 3 months tops. Not new data just a different analysis of existing data. If you read it the panel voted in favor of pre-approval. This is the facts.

Maybe, but there could be a delay of up to a year. No sense arguing. Today is Monday and tomorrow is PUDUFA,,

 

[Anonymous]

additional analysis of the existing data
Which tells me 3 months tops. Not new data just a different analysis of existing data. If you read it the panel voted in favor of pre-approval. This is the facts.

New data could mean 2 yrs or more. Analysis,of existing data will probably be 6-9 mos.
Seen it before

 

[Anonymous]

New data could mean 2 yrs or more. Analysis,of existing data will probably be 6-9 mos.
Seen it before

The New England Journal of Medicine yesterday published studies on a new drug, tofacitinib, to treat rheumatoid arthritis. The drug was due to be approved later this month, on 21 August, 2012, however the FDA has recently requested further data analysis be performed which is likely to delay the approval of the drug until the end of the year and, if approved, it will probably not be available until early 2013.