Antibe Therapeutics Inc(Pre-Merger) T.ATE

RE:RE:RE:RE:Lull before Pop?

[CalgaryATE]

If you double check the past 2 MD&As, you'll see that they removed the plans that they were going to apply for a fast track designation.  They also switched that they were expecting to conclude IND-enabling pre-clinical studies in calendar Q4 2021 - to ---> initiating human trials in calendar 2022.

Realistically I'm not sure if applying for a fast track designation before the IND-enabling pre-clinical studies are complete would be helpful (since we'd still be awaiting animal data for the FDA to analyze).  I'm also not sure if fast tracking would be that helpful once we have the final animal data either since the FDA is supposed to give an approval within 30 days of submission (which seems pretty fast as is).  I suppose fast tracking might be helpful once 352's phase 1 trial is underway?  In an interview mid-April (4 months ago), Dan said phase 1 would start around 12 months (then said with FDA being slow might be 15 months).  So an April-July 2022 start for 352 phase 1.  He also said the trial would take about 6 months (since gradually increasing dosages once lower ones were shown to be safe).

So in my opinion (and I could definitely be wrong), fast tracking might not really prove helpful until about a year from now.  That being said, though I've always found Antibe to not be very pumpy (though a bit of an increase in more recent times), I suppose a news release saying that we have successfully had 352 approved for fast tracking by the FDA would be positive PR.  They could save the application and approval of fast tracking so that they could release it (and any other postive news they could save up) around the time of a nasdaq uplist / phase 3 otenaproxesul start.


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From the February 2021 MD&A

Development Status. Antibe has confirmed the non-addictive properties of ATB-352, targeting the significant market for acute pain. In addition, pre-clinical studies have demonstrated that ATB- 352 caused negligible GI damage compared to ketoprofen.3 On June 3, 2019, the Company announced that it is targeting post-operative pain as the lead indication for ATB-352 and plans to pursue a Fast Track designation with the U.S. FDA to expedite the development and regulatory approval process. Antibe has commenced IND-enabling pre-clinical studies for ATB-352 that are expected to conclude in calendar Q4 2021.


From the June 2021 MD&A

Development Status. Antibe has confirmed the non-addictive properties of ATB-352, targeting the significant market for acute pain. In addition, pre-clinical studies have demonstrated that ATB-352 caused negligible GI damage compared to ketoprofen.3 On June 3, 2019, the Company announced that it is targeting peri-operative pain as the lead indication for ATB-352. The Company is also pursuing the development of new intellectual property for ATB-352 to lengthen the duration of patent and market protection (see “New Chemistry Initiatives”). Antibe has commenced IND-enabling preclinical studies for peri-operative pain and anticipates initiating human trials in calendar 2022.

MrMugsy wrote: Ya - I once asked Dan about fast-tracking OTENA (around August of last year).
I think his answer was ... there's no point now.
I didn't challenge further as I moved on to another question.

Which begs the question now ... when is the right time to fast-track 352?
As I understand it ... you can complete the paperwork at any point in the development cycle.

Thoughts ?

 

mstrmnd wrote: tuah nod

All valid points but disruptive medical angle trumps all, meaning adoption because of superiority - both prescription and non-prescription markets and here's the kicker...it comes in a pill...what one may imply as obvious is in fact highly desired when looking from a different angle

Is it an anti-inflammatory with an improved GI side-effect profile

OR

Is it a mucosal healing wonderdrug because of its anti-inflammatory properties?

I can fast-track this bad boy, but Dan is MIA

MrMugsy wrote:

mstrmnd wrote: Is it the lull before the pop?

Are we closer to a partnership than we realize?

Tough to say mstrmnd.
I'm sure we better know who's in the running now.
Also, I'm sure we better know who could benefit the most from an OTENA partnership - including future H2S drugs that we have in development.

I think about two types of Big Pharmas at play right now ...
1.  Big Pharmas who are "pain and inflammation" leaders today.
2.  New entrants with or without a weak competitor in the "pain & inflammation" space.

In any value analysis (re. OTENA), I would think that a new entrant would put more value on OTENA than a leader in the "Pain and Inflammation" space.

The leaders will continue to make residuals on the old drugs long into the future - while - a new entrant will pay more to get a leg-up with OTENA - in a space where their revenues are close to zero.  So, if I were ATE ... I'd be looking at all potential partners but really trying to sell the merits of OTENA to a newbie.

A potential partner is going to need to see how we can extend the existing IP beyond the present time frame.  We're only starting that process with Dalriada but this could easily change the value of OTENA (IMO).

Being in the confidential part of negotiations, it certainly is an interesting time.  Does someone flinch and make a quick move to secure ATE's OTENA?  They are all likely waiting for the remaining studies to be completed so they can further evaluate what they are bidding on.

No idea where it goes from there.  That's what makes this so exciting to watch.  There should be some nervous "Pain & Inflammation" leaders and there must be some hungry new-comers.  If so ... then we take our sweet time to figure out the best fit.  Others could also join the discussions last minute.

Just making sure I'm ready for it.