Hello all. Firstly, hi to Phillip and KB. Will say hello in person next time, now that I know who you are. Apologies for the delay sharing my thoughts and I only have time for a very quick summary. I can elaborate (Phillip or KB may be able to assist here) should anyone have any specific questions on my notes below – assuming my memory allows. Point form (literally from my notes and recollection) is all I can offer at present. I hope it helps in any case:
Funding
Strong cash position and great relationships with stakeholders showing continued support. Supportive shareholders and potential for non-dilutive funding from organisations (like Rettsyndrome.org).
Strategy
Alignment with the FDA is key. NEU are “in a far greater position post the FDA meeting”.
There was ‘overwhelming support’ from the FDA in the recent meeting. Attendees from all areas of the FDA showing NEU love, care and encouragement.
RT said that it would be remiss of him not to flag the significant interest NEU has received from big pharma over the last 12-18 months.
Given the potential market sizes, success in only one of the targeted indications WILL MAKE NEU.
Manufacturing
Achieve commercial scale and reduced unit cost in the manufacturing process. This is critical to have down pat when entering partnering/licencing discussions.
NEU are contracting 2 scale manufacturers as they don’t want to be tied in to just one (and therefore be a price taker).
Very unlikely that NEU will set up their own factories/plants etc to manufacture. Large pharma contractors already have the facilities to sub out to.
Rett
NEU to propose a subset of the 37 MBA criteria that will form the PIII endpoint.
FDA encouraged the ‘children’/paediatric 5-15yrs trial. Will be easy to recruit as unlikely to be placebo controlled and kids are much more accessible (in that they are usually still at home etc)
4-6 week (FDA said ‘breif’) trial to start 1H16. Data in 2H16. Slightly smaller trial group (45-50 was my estimate based on RT’s comments).
NEU will enter/agree an SPA with the FDA for PIII trial.
Re. Breakthrough
Doesn’t change ANY requirements, only potential FDA access/resources. RT noted that the FDA turnout at the meeting was certainly in line with what you would expect were we granted breakthrough. I sensed RT was sick of discussing not achieving breakthrough and reiterated that the FDA were VERY supportive of our way forward.
FX
Last patients enrolled and completing study (Oct/Nov) with December results.
No hiccups/no difficulties
Noted a surge in recruitment in the last 6 months. Noted possible reasons as additional sites and drop of eligibility age, and as Phillip has noted, RT was VERY careful not to comment on the social media comments and reminded the room that the trial was blinded.
Consolidation
Looking at daily fluctuations on market is futile (unless a trader of course).
NEU us well supported on the ASX. Certainly not interest in NASDAQ listing at this point (but never say never).
Of course there was a lot more colour and I have my own interpretation of the notes above, but RT’s reminder of his and NEU’s mantra was very important to me and worth reminding all longs:
NEU are working toward getting trof out to those it can assist asap whilst working to maximise shareholder returns.
I was very impressed by Dr T. He appears confident (not arrogant), but confident in that he certainly knows his stuff. I’m happy of where NEU us headed and more than happy to have RT at the helm.
Cheers all. Frogga.
Disclosure: I purchased additional shares this morning.
NEU Price at posting:
9.9¢ Sentiment: Buy Disclosure: Held
(20min delay)