@NewbieHK - Yes, I am similarly minded on this.

I'll probably accumulate up to a 3% position on any SP weakness (from current 1.6%) over the next 3-4 months, which will make the return over the next 2-3 years when the SP takes off on early revenue growth meaningful for me at a portfolio level without staking the farm. Of course, as I continue my research there is always a chance my conviction could increase!

Regarding SP moves, in the absence of any further news flow, I'd expect to see investors seeking to trade the FDA approval milestone starting to move in throughout Q2. The return potential in the few months before and after approval (or days, depending on your trading horizon!) combined with the risk-reward profile should make this a very attractive mid-2024 trade for short term money.

On Japan, Kaken have recently upgraded the sales forecast of ECCLOCK.

• In 2Q FY22 sales were JPY1387m up 69% from JPY823m in the pcp
• So, the FY23 forecast has been increased to JPY2100m from JPY1900m, which if achieved would be +67% on the PCP

So, the product is doing well in Japan, albeit at a muck lower price point that planned for the US. Reasons for success in recent reports have been cited as:

• "Ecclock sales amount increased thanks to increased disease recognition of primary axillary hyperhidrosis." and
• "For Ecclock, net sales increased due to release of twist-type bottle and increased recognition of primary axillary hyperhidrosis" 

Of course, thinking about this sales growth profile, I will contradict what I wrote earlier today ... perhaps the EH assumptions for the US are OK after all.

Overall, I agree with you, it is very rare to see this kind of risk profile around a company at the pre-NDA approval stage. And because its a small cap, I expect there is some market inefficiency at play. Which is why I'm here!

Hi @mikebrisy Those Kaken upgrades on Japan sales are significant. I wouldn’t be surprised to see more upgrades as it gains traction. i

I wonder if the earlier than expected re-submission potentially means an early than expected approval?

As was the case with this mornings ASX release. The indications and expectation was this re-submission would take place early in 2024.

Consequently, traders may be forced to enter earlier than they had planned in case they miss the pop on the official FDA notice.

Just a thought.

Hi @NewbieHK,

I suspect you are right. I think in 30

days we are more than likely to get an announcement from FDA that there will be a fast track 2 month review which brings approval forward around March.

The fact safety data package from Kaken was sent early with this packet and this wasn’t due until March is a hint. Read between the lines they are under promising and will likely overdeliver. Which means a possible rollout and revenue April / May.

Possibly a final capital raise post FDA. Or to stir the pot they have been given a nudge and told we will take you over the quicker you get this approval the faster you get an offer?

@NewbieHK it would be great to think that approval and sales elsewhere in the developed world would mean the FDA approval would be a slam dunk. But it doesn’t. I’ve made a similar assumption before and lost heavily!

not a comment on the investment thesis for Botanix, just an observation