Severance Packages being finalized by HR

This is not good news for us!

 

Says who? Piss off A-hole

 

Hey guess what? To OP poster, severance packages have been created for months in the event the drug is not approved. They told us this on a national call and directors have told us this! No surprise! They are saying "In the event of a denial." These packages take a long time to create through HR and they could never do it last minute. Of course everyone is acting full-steam ahead as if it is getting approved currently. In any outcome, they cannot make it seem there will be a denial as the stock price would crash prematurely even before the actual denial, which would make the overall stock price go down even further. Do people just not get this? This has to be done. So let the acting continue as if everything is a go. Most realize this isn't happening.

Do people really think they know anything yet? No they don't. Even if they did know, they would act like it is getting approved or then there would be severe consequences with the stock price.

 

Agreed. Leadership has to play the game as they can't show their cards to the outside world as it would be detrimental to the value of Biogen. They are not working on a label. Don't believe it? Just ask!

 

Michel needs time to dump stock.

 

A very good chance there will be a denial. I just heard today they still haven't worked on a label.

 

Well, if that were the case, then Biogen would have received a letter stating that deficiencies preclude labeling and post marketing discussions, which would have been made public. Since the last version of PDUFA (V), you either get the first draft of the label and begin the negotiation process a month before PDUFA date or that letter. Look it up in the FDA’s website. It’s pretty standard now that publicly traded companies make that later public for transparency to stake holders.

 

This is a very interesting topic. I believe the FDA will require additional study before approval.

 

Of course it is a given Biogen provided the supplemental New Drug Application (sNDA) to the FDA, but whether it will be approved or denied is anyone's guess. It truly is a coin toss.

 

Never. Getting. Approved

 

Adu reps are radioactive. I got chewed out for suggesting we interview one.

 

Sure buddy

 

What is a given? I don’t think you understand the post that you commented on. The FDA completes the review of the data portion (non-manufacturing) a month before PDUFA. They are required to give the first draft label one month prior to PDUFA if the data portion was approved. They don’t give the label if it did not get approved. Instead a letter is sent stating that deficiencies preclude label discussions. That is made public by the company due to transparency to shareholders. Is getting a label a guarantee? A CRL could still be issued due to manufacturing issues, which happens quite often, especially during the pandemic. It’s a pretty quick fix, though.

 

then they would have issued a that letter

 

That isn't true at all. If that were the case, then everyone would say it is approved and that isn't the case. The only thing that is happening is negotiating. This happens all the time and in the end, the FDA could say we want another study to approve.

 

The CRL will be a no.

 

Of course. The FDA will require more data, and they should. More than likely, they will request a second phase 3 trial to prove the efficacy is repeatable, which clearly hasn't been shown yet. That is the minimal request. Only makes sense.

 

Why do you fools even care what happens? Lmao

 

https://www.fda.gov/media/78941/download

It’s not a guarantee, but “likely”…especially since the only issue is lack deficiency of data, not safety.


4.14 Develop Final Labeling, REMS and PMRs/PMCs
When significant deficiencies preclude discussion of labeling, REMS, or PMRs/PMCs, those deficiencies are generally communicated in a Discipline Review letter(s) by the target date identified in the planned timeline (See MAPP 6010.8; see also section 4.9 of this Guide). If the application will receive a Complete Response letter, the action letter may include the division’s proposed labeling. The “complete response” letter will also include the REMS requirement, if it is determined that a REMS is necessary.
If the application is likely to be approved, labeling (and REMS, if applicable) discussions, taking into account review wrap-up determinations, proceed between the review team and the applicant and continue until agreement is reached on the wording and final labeling (and REMS) is produced. . For NDAs, BLAs, including applications in the Program, efficacy supplements, and PLR-conversion labeling supplements, the RPM should make every effort to email the clean version of the agreed-upon PI to the SEALD Labeling Reviewer at least 3 to 5 business days before approval (See MAPP 6020.16). Labeling discussions beginning too close to the end of the review cycle frequently result in inadequate time available to discuss labeling that both the applicant and the Agency can agree upon.
As with the labeling and REMS, the review team and applicant work to develop PMRs/PMCs, as appropriate, with input from OSE and the review division director, deputy director for safety, and the ODE director, if the signatory authority (See MAPP 6010.9).

 

Likely why the put call ratio for $biib over last 10 days has been cut in half compared to 30 day. It’s under 1.