Bioshares recommendaTIon to wait is eliminating the risk factor totally. It is also eliminating an opportunity. Individuals should weigh risk v reward.
The key points to consider and Primas actions regarding them are:
1. The IND application:
'The appointment of Pfizer’s former Director of Global Medical, Ms Ginny Raymond....with a specific focus on overseeing the successful passage of the Investigational New Drug (IND) application with the US Food and Drug
Administration (FDA) for Prima’s CVac™...'
2. Full clinical trial protocols:
'The IND submission is being managed by former US FDA Deputy Director of Cell and Gene Therapy Dr. Joyce Frey-Vasconcells.....'
Waiting certainly cuts out the risk, however taking some risk means entering the market at a cheaper price which adds substantial leverage down the track IF things are successful/positive.
I don't know if 'we are almost here' yet. That depends on each individuals investment strategy (short, medium or long term). Gaining IND approval and commencing trials will be a hugs milestone. Orphan drug status is an important, but not vital element which will add huge potential. The transition from Phase 2b to Phase 3 pivital trials will be the milestone which should silence some critics and gain the support it deserves (& better finance arrangements), if it occurs.
It appears to me that Prima are doing all they can to get Cvac through each milestone. The funding which they have organised although not ideal has allowed them to progress or reach a milestone. I anticipate more favourable funding will be arranged as Cvac progresses. Fortrend gave them breath and SpringTree allowed the IND application and trial process to continue. Does anyone really expect the full $25.5m to be used? More favourable funding should likely be arranged as Prima becomes a more attractive and less risky opportunity.
LETS NOT BE OVERLY POSITIVE OR NEGATIVE - LETS STICK TO THE FACTS. AND THOSE NEW TO PRIMA PLEASE DYOR.
Regards and good luck to all holders.
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