RE: operational update7 Mar 2023 10:33
Morning The.Italian,
Although the FDA process is ticking along, there still seems to be a lot of incompetence given their previous announcements.
According to the June 6th/22 Update....
After incorporating the FDA’s suggestions and recommendations into the Phase 3 protocol, the Company’s clinical research organisation has also completed the Phase 3 Study protocol, together with a ‘Type C’ meeting request, with the FDA for the product development of Fortacin. This meeting between the Company and the FDA should occur by mid to late September 2022 (being within 75 days of receipt by the FDA of the meeting request). We are hopeful that after providing a fulsome reply to the FDA’s advice and request letter and incorporating the FDA’s recommendations and suggestions into the Phase 3 study protocol, that the Company can proceed with its Phase 3 study shortly after the ‘Type C’ meeting.
Yet, they now state that the Type C meeting request wasn't made until Dec. No explanation has been given as to why their request for a meeting was refused, although there was some teleconf!!!
I also notice that they write that a clear NDA submission pathway has been agreed with the FDA, yet that agreement was already in place as announced in the PLE RNS 9983B. "Food and Drug Administration ("FDA") has now unambiguously defined the path to a successful submission of the New Drug Application"
As I wrote previously, given how long they have taken with the phase II, I really don't expect FDA approval till late 2025, if not 2026, which is incredible after they stated they would have approval by June 2017 in the first place (June 2018 with the extra 12 months for the 6 dose can debacle) . It certainly calls into question who is making it up...the FDA (I doubt) or our management.
I think everything now relies on China, which, I am sure will progress on schedule. They certainly make ERP's efforts laughable (and it even started 3 years after the US and that's allowing for a years delay because our lot hadn't checked the Chinese authorities had the necessary approval paperwork for the drugs used).
Anyway, it will be interesting to see how things progress with Recordati as there are no more excuses. And of course no more mention of PSNW who I guess have been sent packing with their tails between there legs.
They need to sort a license agreement this year otherwise it'll be further dilution (if Recordati don't sell many cans)