De troefen van Cydy of moet Cydy kleur bekennen?
1. While it's true that the company has relied upon raising money through debt, that is something that is true for any pre-revenue company, and certainly pre-revenue biotech companies.
Geen commentaar. Het zit veel ingewikkelder dan dat - zoveel weet ik wel.
2. Cytodyn has completed a successful phase 3 trial for HIV combo therapy
3. Cytodyn is in the process of re-filing a BLA (underway) with the US FDA to support revenue for the HIV indication
Ze zijn al 3 jaar bezig met een correcte BLA. Is niet meer geloofwaardig dat dit onderzoek deugt.
4. The CD12 trial data provided strong information that implies a very significant, dose dependent mortality benefit for critical COVID patients.
Dit is niet bewezen en het onderzoeksvoorstel is afgekeurd.
5. Per US FDA direction, the company has developed a new critical trial protocol, which has been submitted to ANVISA in Brazil, to complete a phase 3 trial in the 2nd half of Brazil to confirm the benefits of the treatment
6. The company has also developed and submitted a mod/severe protocol for a second trial in Brazil to support broader COVID coverage
Je kan zoveel onderzoeken starten als je wil - zolang je geld en middelen kunt vinden. Het is niemands belang een onderzoek bij voorbaat af te keuren als het erop papier goed uitziet. Het lijkt echter een herhaling van zetten.
7. Beyond these more immediate potential use cases, research being done by Dr Bruce Patterson supports the use of leronlimab in long haul COVID patients.
Die man heeft hele andere insteek en belangen.
8. The company is wrapping up a phase 2 trial for long haul COVID and plans to move forward with a phase 3 when ready. The market for long haulers should greatly exceed that for critical COVID in the long term.
9. The treatment, based on its MOA (blocking the CCR5 receptor to modulate and optimize the immune response, not my words, but Dr. Otto Yang's words) has a number of other potential indications, including the complete prevention of HIV, treatment of various cancers, NASH, and others.
Nieuwe hoop, niets concreet.
10. With regard to initial sources of revenue, it appears that Chiral Pharmaceuticals has issued a PO for leronlimab sales in the Philippines, to cover the Philippines blanket CSP granted to allow hospitals there to stock treatments for up to 100 patients per hospital.
Geen officiële goedkeuringen.