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Hi Fuma

In late March, you mentioned TCDA in one of your posts, and I began a starter position. They just had an earnings CC on 5/7/2020, and indicated the NDA was on schedule for August 22, 2020. You wrote that you suspected the date would be sooner than that date. In addition, the TCDA website also indicated a potential NDA approval in the 2Q of 2020. August is in the 3rd quarter, so is this a disappointing update in that the NDA approval has not been moved to a sooner date?
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Not Fuma, and I'd like to hear his thoughts. I didn't see anything in the conference call notes that raised a flag. More important, it looks like their plan to build out their sales network is proceeding as expected. But I don't know what I don't know.
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is this a disappointing update in that the NDA approval has not been moved to a sooner date?

A quarter off, meh. The FDA had been pushing things through pretty quickly and ahead of schedule so there is still hope? I wonder if the covid card could/would/will be played, though I suspect TCDA is above that. Specifically, one could argue that hey, with this medication a slew of potentially higher risk folks don't have to start dialysis and don't have to potentially be near a large gathering of other at risk people.

Not sure how I feel about plowing forward and don't recall what the CEO did with his other renal drug companies that were one trick ponies. Not sure if it means they're really holding out for a big payday or what. I can't imagine the plan all along was to create a functional company that would mature into a profitable business with a pipeline long term, but this drug certainly seems capable of selling more annually than this companies current market cap. I've bought 3 times this year in my retirement account and it's 4.5% of my port right now... So I'm not too worried about the investment.
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https://seekingalpha.com/news/3591669-fda-flags-deficiencies...

Nothing too specific but there’s no way this doesn’t get approved. Am I naive in thinking this dip is free money?
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Nothing too specific but there’s no way this doesn’t get approved. Am I naive in thinking this dip is free money?

DOrtiz92, I appreciate your confidence since I own some shares, but I don’t know how often an FDA notification like this is successfully addressed. May I ask what gives you your confidence?

Here is the PR from Tricia:
https://ir.tricida.com/news-releases/news-release-details/tr...

However, at this time the Company is unable to evaluate whether it will be able to address the FDA’s concerns.

“We are surprised and disappointed by this news,” said Gerrit Klaerner, Ph.D., Tricida’s Chief Executive Officer and President. “We continue to believe in the potential of veverimer to be disease modifying and our goal is to work with FDA to identify and resolve the issues in order to bring veverimer to patients.”


John
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Was going to post on this today; briefly talked about this with cosmid.

Their data is clearly positive, the CEO has gone through this all before successfully in the kidney market.

We think it sucks, but if you haven't gotten in, now is likely a good time. They're arguing about labeling and post market surveillance; not efficacy.
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They're arguing about labeling and post market surveillance; not efficacy.

Thanks Fuma. I guess my worry is that I think labeling can hugely impact how big the market is for the drug. But we don’t know what the FDA’s beef with labeling/postmarketing is and I trust the Experienced CEO.

Regarding my own shares I’m inclined to let them ride. I once owned shares of a drug company who had their PDUFA date postponed by 3 months after the FDA said they needed the extra time due to the drug company supplying additional information regarding the proposed drug’s manufacturing facility.

The unexpected delay produced a +20% overnight drop but shares recovered within weeks.

We’ll see, good luck,
John
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This wasn't terribly unexpected, though apparently Wall St thought so.

I'm a bit at a loss in more ways than one, and was one of my highest conviction biotechs. I still believe the data and management.

It is beyond belief that crappy data/no data/ potentially harmful treatments like convalescent plasma and Impella makes it by the FDA and something with mounds of sounds RCTs with good outcomes for a high critical need gets a smirk from the FDA.

I'm sorry folks. I'm still holding but not adding. I don't get it. This should have been a shoo-in.

This is like the first miss that cosmid & I agreed on in close to ten or more investments. We're still in shock.
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Baffled by this one. Hoped to get more insight into what went wrong with TCDA. Instead I found stuff like this:

a) veverimer has a novel surrogate endpoint
b) there is little precedent for accelerated approval of cardio-renal drugs

Huh? FDA accepted the surrogate endpoint and now is... well...., not so accelerated

FDA determines that precedent is a factor in granting accelerated approval? This is an easy one. If precedent matters, don't grant accelerated approval in the first place.

Major disconnect between the bodies within FDA who grant breakthrough and accelerated status and the actual voting panels and TCDA is the middle, IMO.

TCDA data is among the most convincing I have seen in over 35 years of biotech investing. This isn't a TCDA problem, it's an FDA problem. I will hold for sure. Probably dead money for a year to two. Might buy more, but will wait another 24-48 hours until I can screw my head back on.

Cosmid
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So I'm going to post a bunch of stuff this afternoon on my holdings. Let's start here.

Basically, the investor powerpoint in August is a good starting point:
https://ir.tricida.com/static-files/ad5a197a-8168-476b-832a-...


“According to the CRL, the FDA is seeking additional data beyond the TRCA-301 and TRCA-301E trials regarding the magnitude and durability of the treatment effect of veverimer on the surrogate marker of serum bicarbonate and the applicability of the treatment effect to the  population. FDA also expressed concern as to whether the demonstrated effect size would be reasonably likely to predict clinical benefit. There were no safety, clinical pharmacology/biopharmaceutics, CMC or non-clinical issues identified in the CRL.”

In English:
The FDA is not convinced that serum bicarb levels are an applicable surrogate marker, and they question if a treating bicarb levels help. Now, normally I would agree, and say surrogate markers can in fact be a smoke screen, except that there already multiple studies showing bicarb levels correlate to progression of chronic kidney disease (read: dialysis).
… and from international guidelines: “Serum bicarbonate concentrations less than 22 mmol/L are associated with risk of CKD (chronic kidney disease) progression and increased risk of death.... We suggest that in people with CKD and serum bicarbonate concentrations <22 mmol/L treatment with oral bicarbonate supplementation be given to maintain serum bicarbonate within the normal range, unless contraindicated”

It does get interesting when you did a bit deeper as there was one study in which, “Our results suggest that at least for patients aged 60 and over with CKD GFR categories 4 and 5, 1.5 to 3 g per day of oral bicarbonate does not produce any health benefits and may be associated with net harms.” .... which would be totally fine, except there are multiple other studies showing benefit.

Now, good science would say, "well, does an improvement of serum bicarb **with tricida's drug** correlate with improved patient outcomes?" - these sort of questions are RARELY asked, and often why I scream into the vortex and often crap all over most biotech companies. So what has TCDA done?

TRCA101 – 2 week P1/2 trial randomized, double blind placebo controlled, 135 patients
TRCA301- 12 weeks, P3, 217 patients (serum bicarb as endpoint)
TRCA301E – 40 weeks, P3 trial, 196 subjects.


301 showed better quality of life, better exercise tolerance, 65% reduction in a composite outcome of death, renal replacement therapy or >50% drop in renal function.

Now, typically I would crap all over a composite outcome (this is what statins did, and its **MUCH** less than a 65% reduction in their composite outcomes!) - but going from 12% to 4% PLUS patient centered outcome improvements is a pretty air-tight case. The only complaint would be number of patients included (500 or so patients all in all). To be clear the FDA has accepted much, much, MUCH less.

So they asked for more data. and TCDA had *already* started their large trial, Valor CKD, with 1600 patients, looking at a primary outcome of delay to dialysis. Randomized double blind placebo controlled trial. ValorCKD was planned on being a post-marketing study. Its been ongoing since 2018, ETA for completion Q4 2022. Protocol specifies an interim analysis when at least half the planned number of primary endpoint events have been accrued -- I suspect an update in 2021, and perhaps resubmission at that time.

I can not stress enough, this is what good science looks like, and good results. TCDA has enough cash to last through mid 2022, $437m.

This is frustrating, especially when there is more bs medicine out there with much less rigorous evaluation. TCDA is dead money until the Valor CKD study. BUT, this is still a 2b or more per year drug, for a company with a 560m market cap and good leadership.

I have plenty of shares, and as a rule try to avoid adding to my losers; but I still like TCDA even though this hurts a bit.
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Thanks Fuma.

I get what you are saying, and I totally don't get the FDA. However, I also don't get why TCDA said they had a marketing issue to get through. Any thoughts as to why they would put that out?

Best,
bulwnkl

Long TCDA: 1 share
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Your guess is as good as mine on the marketing.

Not really my realm, but best guesses are that FDA didn't like how much they leaned on advertising bicarb improvements? Or Quality of life improvements?

Again, they have approved items on much less data with more aggressive labeling. I'm baffled.

Also should point out that I'm unaware of a a competitor in the arena right now, so it's not like someone else is going to best them to market.
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Is there any chance that TCDA can resolve this without more data in their meeting with FDA this month?
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Good question. Not a ton of experience at this particular issue, though I think best case right now is approval on interim data analysis of VALOR-CKD trial... Which is possibly mid 2021.
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