Ann: Positive Pre-IND Guidance from FDA on Zantrene, page-40

After re-reading the Ann here are a couple more thoughts:

- Race has presented historical clinical data to FDA which FDA has reviewed and is comfortable that it still is valid today and hence can be used to justify the 505 (b) (2) pathway. This is a HUGE deal IMO. While I posted this earlier today, this point cannot be overstated. First of all, the 505 b2 pathway is not easily approved by FDA. Secondly, the clinical data would be historical because we are just in the clinic only for EMD AML and we don’t have this data. If FDA has rubber stamped this historical clinical data, BP will of course swallow it. Also, Race would have presented the new pre-clinical data which again FDA would be comfortable and happy with. Double tick for clinical and preclinical data.

- This FDA nod probably is a huge deal for instos and retail investors, and potentially BP to get interested in Zantrene as any doubts on the validity of the historical data is now removed. Further the ability to open IND and conduct trials in USA means when the drug has to be taken to next round of trials using the 505 b2 pathway (plus a potential PRV) means the trials can move faster for marketing approval and into the clinic. Combine this with extended IP protection from the new IV formulation, assuming that Zantrene can be FDA approved and marketed soon after, the acquiring BP will still have about 17-18 years of patent life to realise significant revenues over that period.

Even more derisked.

I am excited for the AGM tomorrow and this news couldn’t have come at a better time.

(AIMO. No advice)