Next Steps...1) Put out a press release explaining next steps
2) Sell VMC and unload salaries
3) Seek out connected US partner with FDA pull
4) Approach FDA for EAP potential.
5) Approach Health Canada about NOC pathway
6) Work alongside Ipsen to move towards EU approval (probably already in motion)
7) Press FDA for second Adcomm panel review for those Unwilling or Unable to have Cystectomy
8) Get Mexican approval (this can be done in months not years with COFEPRIS) for cross border access to US market for refractory patients
9) Work with the FDA on new regulatory pathway
10) Work with Japanese and Korean Regulatory bodies towards approvals.
Please add to the list as you see fit.
beech