CytoDyn $CYDY mit Blockbuster Potential WKN: A0YHA5 (Seite 922)
eröffnet am 04.04.19 22:54:12 von
neuester Beitrag 29.11.23 15:46:05 von
neuester Beitrag 29.11.23 15:46:05 von
Beiträge: 30.091
ID: 1.301.376
ID: 1.301.376
Aufrufe heute: 8
Gesamt: 3.062.131
Gesamt: 3.062.131
Aktive User: 0
ISIN: US23283M1018 · WKN: A0YHA5 · Symbol: CYDY
0,2100
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Letzter Kurs 22.05.24 Stuttgart
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| 2,2850 | -13,45 | |
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Guter Rat: Nützt die Funktion "Beiträge des Benutzers ausblenden". Eure Zeit ist kostbar und das Forum wird für Euch dadaruch noch viel besser. Hinzukommt, dass Trolle dann meist mit der Zeit verschwinden (oder dann ihre Zeit verschwenden und nicht meh die Eure).
ja, richtig erkannt, ich bin "Frank" und poste öfters auf yahoo finance zu Relief T und Cytodyn (seltener zu Vaxart).
Habe eben an Scott Kelly (Cytodyn Chief Medical Officer) folgendes email geschrieben:
I am senior scientific...........I was working for a national drug authority in the EU and also the European Medicine Agency for several years in London (now it is in Amsterdam thanks to Brexit). I studied veterinarian and did my pHD in Virology. I briefly introduced myself to show that I have a scientific and regulatory background. Now I am dealing with the safety assessment of.......... for the EU Commission (not dealing anymore with drugs). Over about 25 years I had to assess a lot of human studies with drugs .......
My email may be completely superfluous, because you may have thought already about the following. I was thinking again about the results of the CD10 results and that the FDA apparently did not found them sufficient to grant EUA. Although in my view the FDA had the margin to grant EUA on the basis of these CD10 results, the position of the FDA was somehow reasonable or at least understandable. However, with the results of the CD12 trial will hopefully show (either at 75 % of 100 % recruitment), the results of the CD10 trial should be revisited. In particularly the following issues could provide strong arguments to the FDA (or other drug authorities) to grant not only EUA for severe and critical patients, but also to mild and moderate on the basis of the CD10 trial supported by the results of the CD12 trial:
1) Lower mortality rate of the CD12 trial would validate and support the statistical significant NEWS2 results and the predictive value of that endpoint successfully met in the CD10 trial.
2) Since a certain proportion of the adverse events occurring in Covid trials are most likely causally linked to underlying disease, this endpoint (adverse events) deserves special attention also in the CD12 trial. If, - what I would expect, also the CD12 trial has a lower number of adverse events, then this would give a lot of support and credibility for the corresponding finding (statistical significant lower number of adverse events) in the CD10 trial in the leronlimab group).
3) The clinical score – same here. That was better, but not statistically significant in the CD10 trial. Again, also here the results of the CD12 trial in clinical endpoints may support the finding of the CD10 trial.
I know from my experience at the national and European Medicine Agency, but also from my current job: consistency and how results across studies do support (or refuse) results of other trials, is a very important consideration in such assessment by authorities. I am quite confident that this applies also to the FDA, because in principle, we (Europeans) and your FDA follow very similar if not the same assessment approach (does not necessarily mean that we always have the same opinion at the end). As a result the FDA may eventually EUA also for mild or at least to moderate Covid-19.
Welcome to Mahboob at Cytodyn. We need you and I think your new job offers enormous possibilities and opportunity. Good luck to you all at Cytodyn ! And good luck for Tuesday!
Small remark, my email was written entirely in my private and not professional capacity.
Habe eben an Scott Kelly (Cytodyn Chief Medical Officer) folgendes email geschrieben:
I am senior scientific...........I was working for a national drug authority in the EU and also the European Medicine Agency for several years in London (now it is in Amsterdam thanks to Brexit). I studied veterinarian and did my pHD in Virology. I briefly introduced myself to show that I have a scientific and regulatory background. Now I am dealing with the safety assessment of.......... for the EU Commission (not dealing anymore with drugs). Over about 25 years I had to assess a lot of human studies with drugs .......
My email may be completely superfluous, because you may have thought already about the following. I was thinking again about the results of the CD10 results and that the FDA apparently did not found them sufficient to grant EUA. Although in my view the FDA had the margin to grant EUA on the basis of these CD10 results, the position of the FDA was somehow reasonable or at least understandable. However, with the results of the CD12 trial will hopefully show (either at 75 % of 100 % recruitment), the results of the CD10 trial should be revisited. In particularly the following issues could provide strong arguments to the FDA (or other drug authorities) to grant not only EUA for severe and critical patients, but also to mild and moderate on the basis of the CD10 trial supported by the results of the CD12 trial:
1) Lower mortality rate of the CD12 trial would validate and support the statistical significant NEWS2 results and the predictive value of that endpoint successfully met in the CD10 trial.
2) Since a certain proportion of the adverse events occurring in Covid trials are most likely causally linked to underlying disease, this endpoint (adverse events) deserves special attention also in the CD12 trial. If, - what I would expect, also the CD12 trial has a lower number of adverse events, then this would give a lot of support and credibility for the corresponding finding (statistical significant lower number of adverse events) in the CD10 trial in the leronlimab group).
3) The clinical score – same here. That was better, but not statistically significant in the CD10 trial. Again, also here the results of the CD12 trial in clinical endpoints may support the finding of the CD10 trial.
I know from my experience at the national and European Medicine Agency, but also from my current job: consistency and how results across studies do support (or refuse) results of other trials, is a very important consideration in such assessment by authorities. I am quite confident that this applies also to the FDA, because in principle, we (Europeans) and your FDA follow very similar if not the same assessment approach (does not necessarily mean that we always have the same opinion at the end). As a result the FDA may eventually EUA also for mild or at least to moderate Covid-19.
Welcome to Mahboob at Cytodyn. We need you and I think your new job offers enormous possibilities and opportunity. Good luck to you all at Cytodyn ! And good luck for Tuesday!
Small remark, my email was written entirely in my private and not professional capacity.
Hallo Hexe, gib doch endlich zu, daß du dich geirrt hast, und Cytodyn doch die bessere Alternative ist. Das kann jedem passieren.
Du mußt es halt nur deinem Geldgeber noch beibringen.
Du mußt es halt nur deinem Geldgeber noch beibringen.
Antwort auf Beitrag Nr.: 65.564.570 von averyzweckform am 01.11.20 19:15:41Ließ die letzten Quartalszahlen und lass uns einfach bis Ende Januar abwarten.✌️
Antwort auf Beitrag Nr.: 65.564.264 von c0mm1 am 01.11.20 18:16:55Nimm es mir nicht übel, aber Du bist hier bisher nicht mit konstruktiven, inhaltlichen Beiträgen aufgefallen, die Mehrwert für das Board darstellen. Daher wäre ich etwas zurückhaltender bzgl. einer Kritik.
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Antwort auf Beitrag Nr.: 65.563.841 von Takado am 01.11.20 17:11:19Bevor du andere Teilnehmer aufforderst zu beweisen, dass Du lügst, wäre es wohl angebracht deine Ausführungen mit Quellen zu belegen.
Ich halte fest, dass Du weder den Cashbestand, noch die Warrantentwicklungen, noch die Herstellungsdetails zu Leronnlimab kennst.
Und warum ich mir Sorgen über Konkurrenz machen soll (welche überhaupt?), falls CYDY im Januar Zulassung erhält, bleibt auch dein Geheimnis.
Ich halte fest, dass Du weder den Cashbestand, noch die Warrantentwicklungen, noch die Herstellungsdetails zu Leronnlimab kennst.
Und warum ich mir Sorgen über Konkurrenz machen soll (welche überhaupt?), falls CYDY im Januar Zulassung erhält, bleibt auch dein Geheimnis.
Antwort auf Beitrag Nr.: 65.563.715 von averyzweckform am 01.11.20 16:56:18Fairer Weise sollte man noch erwähnen, dass sie noch circa 1 Millionen Dosen haben müssten. Das ist ja auch schon was.
!
Dieser Beitrag wurde von FairMOD moderiert. Grund: Korrespondierendes Posting wurde entfernt
Antwort auf Beitrag Nr.: 65.563.715 von averyzweckform am 01.11.20 16:56:18Gegen Ende September hatten die circa 20 Millionen Cash richtig? Die Schulden an Samsung bis Ende des Jahres betrugen circa 31 Millionen richtig? Ich alleine kenne 4 Medikamente die in phase3 sind. 50 sind aktuell in Studien. Also werden mit Sicherheit mehr in phase3 sein. Also Beweise, dass ich die Unwahrheit sage.
Ich würde auch darum bitten nicht das Geschwafel zu zitieren. Wenn man Beiträge schon ausblendet, sollen die nicht so doch noch zu lesen sein. Danke sehr!
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