Could not have said it better myself @Uboy
however @Uboy
HC is a minefield
Are we being primed LOL
Lets wait and see
On a side note
Anyone else privy to this type of Info
While the company is yet to confirm its path forward, given the high cost of pivotal trials we currently model ANP deferring initiation of the US based Phase IIb/III trial until after the efficacy of ATL1102 has been confirmed in the European Phase IIb trial.
I know i said that the US trial would not be as advanced as the EMA trial but the above is a HUGE STATEMENT
Deferring for 2yrs FDA route
They then go on to say
If the results of the European Phase IIb trial are positive, ANP might consider applying for US approval based on the European trial data without conducting a separate US pivotal trial, subject to the feasibility of such a route.
Again this is a HUGE STATEMENT
SO WHERE DOES THIS PUT PARTNERING TALKS
It does say subject to it being feasible
SO would it be feasible to take on the partner now to pay for our EMA trial + Cash and Script and structuring a deal for the FDA rights for the partner, should the EMA trial be a complete success at which point, a milestone payment over and above the upfront and trial cost, would be paid followed by commercialisation milestone payment plus royalties and we keep the EMA 100% fully commercialised
This would not be a bad route to take if the FIGURES STACK UP
and they the PHARMA PARTNER would not be risking $1.1bil upfront to lose it all like Roche did with Sarepta if our trial fell over
If something like this does not come to market prior to starting the trial and we go it alone and the trial is a success and can be taken to market through the FDA
WELL YOU TELL ME WHAT WE WILL BE WORTH
I just do not like the bit about the CR in the report
Like i said are we being primed as being fair value for one last cheap shot LOL
This should bring out debate, because i could go on, but do not want for fear of getting tiresome and repetitive so will look to others for feedback on this.
SEE HOW WE GO
- Forums
- ASX - By Stock
- PER
- Ann: US FDA Feedback on Type C Meeting for ATL1102 in the US
Ann: US FDA Feedback on Type C Meeting for ATL1102 in the US, page-140
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