PAIN THERAPEUTICS WKN: A2PGL8 ISIN: US14817C1071 Kürzel: SAVA Forum: Aktien Thema: Hauptdiskussion

Danke Johann

Super, danke 👍

Danke für die Infos

Dies scheint mir sehr schlüssig und die FDA wird auch dementsprechend reagieren.

Hier noch ein interessantes Statement aus einem anderen Forum zur "Citizen petition"-beurteilung der FDA: IMO, the CP and the Class Actions fail to state a claim, and they should all be tossed out as by the FDA and Courts as frivolous. To gain FDA action, the CP must make a showing that the claimed behaviors caused a threat to public safety; but I cannot identify even a single claim that anyone who is taking Simufilam is suffering any SAE or even any AV that are out of the ordinary and would be of concern. We all know that Aduhelm causes nearly 40% to suffer brain swelling, and its profile is very heavy on side effects and light on benefits; while Simufilam has shown the opposite, ie significant improvement in cognition and biomarkers, while no risk to the patient so far. So, it is simple, under FDA rules which prohibit stopping or slowing an ongoing trial that could bring benefits to AD patients, they MUST disregard the short seller’s petition as just another “shenanigan”. I believe it should be promptly rejected. As to the Class Actions, they have all been filed because the CP has caused the stock to fall. There was no fraud alleged in the CP, only “suspicions” of some kind of scientific errors and suspicions of possible fraud, but not one instance of actual fraud. The CP is a gigantic FUD so far, unless they prove fraudulent intent as the underlying claims are mostly Rule 10B5 of the SEC act, which requires a complaint that asserts actual fraudulent intent, or something called scienter in these cases. It will take some time for the court to sort this out, but SAVA will no doubt try to get the court to dismiss all the claims on the grounds they don’t have enough facts to support claims for fraud. A high percentage of such cases are dismissed by the courts, but we will need to see how the initial motions are handled. It is extremely unlikely the claims will ever be tried in court since these cases are either tossed by the court or settled usually. The real issues are going to be decided during the PH 3 trials. Those issues are is Simufilam safe and efficacious. Safety seems likely based on the undisputed results so far, and the upcoming 12 month readout should be almost decisive of the outcome of the PH 3 trial if the improvements persist as we have seen reported in the past. You have to remember that SAVA does not create the cognition reports. It is the investigators that do the tests in the different facilities, and none of the Short seller FUD has even claimed the investigators are conspiring to fake the cognitive improvements. If the 12 month report shows large size improvements again, that will go a long way to guarantee that bigger trials with more patients will get the same results.

Und wenn es einmal nachhaltig steigt gilt: wer die Aktie nicht hat, wenn sie runter geht, wird sie auch nicht haben, wenn sie (plötzlich) nach oben schiesst…

Hoffe wir bekommen bald grandiose News, zB partnership mit Pfizer, dann sehen wir hier vielleicht nach nur 1-2 Tagen wieder 100€!

https://stocktwits.com/Usmantanvir04/message/376795155

Ab 14 Uhr können die Amis kaufen/verkaufen

Nochmal kurz die sl abfischen?

Ich meinte die short seller Zahlen

@Sallie: Wo steht das? Hast du eine link?

Sollen die Zahlen nicht am 9.09. rauskommen?

Die Shorts müssten diese Woche doch covern oder? Weiterhin könnten diese Woche noch die 12-Monatsergebnisse veröffentlicht und Phase 3 offiziell eingeleitet werden. Sofern nicht, spätestens Ende des Monats. Wie seht ihr das?