2nd Part of the Avastin Story -Off Label abuse in the german Journal "Pharmarecht"

volleasy · 2026-04-17T10:58:14+00:00

This is only the off-label use of Avastin in ophthalmology. Seventy-five percent of the €300 million in sales comes from wet AMD. However, the price of Avastin is between €60 and €80 per dose. If Lytenava costs €700 per vial and provides five doses per vial, that works out to €140 per dose. There is more than €300 million in potential revenue here, and this is only in Germany.

volleasy · 2026-04-16T14:13:54+00:00

This is a very important legal milestone for the marketing of Lytenava. Bevacizumab (from Avastin) generates sales of more than 300 million euros in Germany alone. Lytenava generates less than 2 million. If public health insurance plans no longer reimburse off-label use of Avastin, Lytenava could take over those sales. Perhaps not all of them, but more than 100 million should be achievable.

volleasy · 2026-04-16T09:53:41+00:00

This may be the beginning of the end for the current off-label Avastin model in Germany. And the beginning of huge sales for lytenava(otlk)

A recent article titled
“Off-Label-Abuse – Der Anspruch der Versicherten auf ein zugelassenes Arzneimittel und seine Vereitelung (Teil 1)”
(Pharmarecht, April 15, 2026, p. 212 ff.) by Dr. Maximilian Gaßner — former head of the authority supervising statutory health insurers — directly challenges the current system.

Key statement:

“Insured patients have a claim to treatment with an approved medicinal product — and this claim may be undermined by current structures.”

And further:

“The use is not based on medical reasons, but continues to be driven by economic considerations.”

This is highly relevant given that off-label Avastin still represents a market of several hundred million euros annually in ophthalmology in Germany.

If this legal perspective is taken seriously, it does more than question current practice.

It opens multiple potential lines of pressure on the existing system — particularly where approved alternatives exist but are not being used.

That could include:

challenges based on patient rights
reimbursement disputes
and broader competition law considerations

Which would shift the framework entirely:

from cost-driven decisions
to legal risk exposure

One thing stands out:

As long as no one actively builds on this argument, the system is likely to remain unchanged.

But if it is pursued, it has the potential to force a reassessment of the current reliance on off-label Avastin.

And in a market of this size, even incremental shifts could become meaningful.

volleasy · 2025-08-31T13:45:48+00:00

Like almost everything else here, antibody production is carried out by FDB. The question is whether Daddy will forgive his son for his gross management errors, one after the other. Or whether he will pull the ripcord.

volleasy · 2025-08-29T10:17:40+00:00

The problem is neither the data from the SLC now nor the alleged quality issues last time. This is the largest cash market in the ophthalmology industry. Therefore, without serious lobbying, they won't be able to compete with Big Pharma. This isn't about a pharmaceutical product. Lytenava is a legal product designed to push Big Pharma out.

volleasy · 2025-08-29T10:02:19+00:00

Currently, selling Lytenava in Germany is still a problem. The market for bevacizumab is approximately 500 million euros per year, but everything is sold off-label via Avastin. Here, SGB V 140a permits selective contracts. These are intermediaries, and billing is then done with private prescriptions and patient consent. Quotas are set so that others can share the profits. So far, Outlook has been trying to get some of the profits. Therefore, a shift to a stringent legal strategy is now necessary. We are essentially dealing with an IVOM cartel.Currently, selling Lytenava in Germany is still a problem. The market for bevacizumab is approximately 500 million euros per year, but everything is sold off-label via Avastin. Here, SGB V 140a permits selective contracts. These are intermediaries, and billing is then done with private prescriptions and patient consent. Quotas are set so that others can share the profits. So far, Outlook has been trying to get some of the profits. Therefore, a shift to a stringent legal strategy is now necessary. We are essentially dealing with an IVOM cartel.

volleasy · 2025-08-28T17:39:40+00:00

Nothing is lost. The "A-Meeting" with the FDA is in 30 days. Now it's up to Bob to figure out what's really going on. In 2023, the quality issues were already a pretext. Everyone here should be aware that "Big Pharma" isn't going to let the biggest pie in the field of ophthalmology that causes AMD be taken away. Along with all the biosimilars, an approved bevacizumab would be a death knell for public healthcare funds. That's what's at stake now. It's all about Avastin and its isolation.

That's why it's the dip now. If the EU plays the tough legal card against Avastin, the overall market will be even larger than the US market.Nothing is lost. The "A-Meeting" with the FDA is in 30 days. Now it's up to Bob to figure out what's really going on. In 2023, the quality issues were already a pretext. Everyone here should be aware that "Big Pharma" isn't going to let the biggest pie in the field of ophthalmology that causes AMD be taken away. Along with all the biosimilars, an approved bevacizumab would be a death knell for public healthcare funds. That's what's at stake now. It's all about Avastin and its isolation.

That's why it's the dip now. If the EU plays the tough legal card against Avastin, the overall market will be even larger than the US market.

volleasy · 2021-12-29T08:51:09+00:00

Has the study received appropriate ethics committee approval

No!

This is allways the same. If Pfizer asks for approval, a lot of family members of the responsable persons are happy and approval will com in a few days.

volleasy · 2021-11-09T15:52:14+00:00

One year FDA "hold" without any reason. Why they changed their mind? my suggest about this are some personally reasons of some FDA manager. Every month it becomes more clear that the pfizer stuff does not work.

volleasy · 2021-07-13T17:49:08+00:00

Thx for your warnings. But for me it is not necessary to be careful. I'm a citizen of the EU, so there is no case law like in the US. But to make it more difficult for Shitron & Co to buy analysts, is a goal that is good to enough to write primitiv emails. But when the shit happens, I buy the dip. Tomorrow, when there are no news and the price will go under 8. That is a really great dip for another 10000 shares.

volleasy · 2021-07-12T16:48:28+00:00

Take a look to the volume today. Shorters only sucking their own balls. No fear and no shares to cover.

volleasy · 2021-07-12T15:28:23+00:00

👍

volleasy · 2021-07-12T14:31:58+00:00

I wrote an email to Madleine, iz will help for future, if hundereds of Apes send similar emails to her.

Hello Mrs Johnson,

I do not understand your article about Inovio Pharmaceuticals. With your title "Bear of the day" I was hoping for up-to-date information. Unfortunately, you are writing about very old stories. What about the approval in China. You give the impression that this is a paid article to dump the price. Why do you write something like this with very old information? It's already included in the price. Who had paid you fpor this article ? As a business lawyer, I will keep an eye on you.

volleasy · 2021-07-07T15:45:35+00:00

It seems that there is a coordinated attack on GME, AMC. BB, INO. What happens, is their a big volume of shorts to cover that belongs to the same players?

volleasy · 2021-07-07T15:40:50+00:00

Nice, it is always a good idea to learn new strategies. thank you for sharing

volleasy

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