Very many thanks for taking the time for your informative...

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Recherche

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16/08/24

17:44

Post #: 75244274
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Originally posted by PigRace: ↑

Hi Recherche,

just in brief:

* First P3 readout in April CY2025, followed by a second P3 shortly thereafter.

* Largest P3 trials in wAMD in history with each having enrolled approximately 1,000 patients. Both completed enrollment in Feb 2024 and May 2024 respectively.

* Largest P2b study ever in wAMD with 366 patients.

* Results of P2b highly statistical significant.

* Only treatment in development targeting at adding to BCVA achieved by existing treatment options while all other drugs in development only targeting at reducing treatment burden, that‘s increasing treatment intervalls from every 4 or 8 weeks to every 12 or 16 or even beyond beyond.

* Majority of currently treated patients achieve only insatisfactory results in terms of BCVA.

* Combinable with all existing drugs on markets.

* 80% of existing market (of insatisfactory treatment options) losing composition of matter patent protection by YE2024.

* Sales potential in case of both P3 not only showing statistical significance (e.g. 3 letters improvement in BCVA over current gold standard) but an entire „line“ (that’s 5 letters and more) realistically should be set around USD 5 billion.

Caveats:

* Financed through read-out only. Meaning there is no real room for P3 failure or „mixed results“ only as money in the triple digital millions from option series at 80 ct and AU$1.00 will be desperately needed by then. Unless they get a partnership done or taken out by big pharma, both of which are a more likely scenario.

* First P3 readout in April 2025 is run against Eylea. Has never been tested against Eylea before as Eylea became market leader (due to slightly better durabiliy, not vision improvememt) only after P2b (against Lucentis) got started. Second P3 is then against Lucentis.

Expand

Very many thanks for taking the time for your informative response.

As a non-technical non-medical new holder I am interested

Is there an online study with milestones and timeline ?

(a) for medical people in my family
(b) for lay people like me

Again ... very many thanks ... trying to get my head around what to watch out for

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Very many thanks for taking the time for your informative...

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Very many thanks for taking the time for your informative...

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