Hi Hottod,
as regards the voucher, the estimate was made by Treagus in the August 22 press release when it talks about Trofinetide sales in North America if approved; it speaks of 350 million plus one-third of the value of a possible voucher that would be paid to Neuren automatically by the FDA as a result of the approval. the FDA has established that a voucher can be worth from 100 to 300 million, so as intriots in general we are certainly in the 400 million range. I probably explained myself badly by suggesting that only the value of the voucher is 400 million, but it does not.
to better understand and respond to the clarifications that you ask me to report the point extracted from the statement of August 22 that should be read well in the lines:
Up to US $ 350 million on the achievement of thresholds of total annual net sales of trofinetide in North
America, of which Neuren expects ACADIA to achieve if trofinetide is approved for Rett syndrome
and Fragile X syndrome.
• One third of the value of any Rare Pediatric Disease Priority Review Voucher awarded by the FDA on
approval of a New Drug Application for trofinetide.
we know that FX is treated in the agreement with Acadia as an option, but it seems that for the company Rett and FX are Trofinetide in its complexity. this aspect, as I have warned him, is a novelty in Neuren's communication from the exclusivity agreement onwards. first we focused totally on Rett and his progress by quoting marginally the outcome of the positive phase of FX as something that had been done, but we could not or did not want to move forward because we did not have the finances available, but they did also said that the trials of toxicity and the production of Trofinetide in higher doses for the phase 3 of Rett were also for the benefit of the rest of the studies that Neuren had conducted so far. after the meeting with FDA in October I remember that those of Neuren had accurately identified the enrollment sites, number of patients, just doses to meet phase 3 with a cost of 1.9 million euros for the production that among other things they had hypothesised feasible for the end of 2018 or the maximum by March 2019. now the expenditure of production increased by a further 2.25 million euros, thus more than double that which they had commissioned for the only Rett; the suspicion that they carry forward in parallel the two trials is strong !!! I add that in the month of July when they decided more than double the production costs, nobody told us anything and we were in the final stages of the exclusivity agreement with Acadia so I do not believe there are doubts in stating that the decision was agreed and welcomed by both.
as far as the immediacy with which other money will arrive is in the timing with which Neuren has released the last two communications; the first to tell us that we suspend and postpone the agreements with Landstead and that in the next 4 months, perhaps some institutional weight of a certain weight could enter the capital of Neuren. then today we anticipate an advance on the six-monthly balance sheet, where we see what we have observed. who will be willing to invest in Neuren as Treagus says, why and above all how ??? until three days ago nobody (apart from us veterans) would have bet anything in the short term and instead Treagus tells us that within a few months Neuren could be very interesting for sophisticated institutional investors; well, from experience on the American market I am very determined in affirming that no institutional investor talked about by Treagus will buy directly on the market, otherwise, they will make money available to experiment and have rights in exchange. the reference is clearly to those who are behind Acadia to deepen the ownership of Trofinetide, but even more to those who have always been interested in 2591 that finally has the conditions to advance or come to the open. if Treagus says that in the coming weeks he will deal with sophisticated institutional means that he has already had contacts and that on the plate he will put something really meaningful, strong of a Trofinetide that for how much do not want to consider, in the month of July he had a acceleration in the production quantity with relative costs. nothing is random.
I hope I have been useful for your reflections
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