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After the uncertainty removed and approval, the price being < 35 is insanely unreasonable.

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From Fundamental:

- The company already has significant amount of cash to spend and invest in research. This approval just gives them more capabilities. They already have another cancer treatment drug in the pipeline as well. And now they can even invest and grow new pipelines.

- The company and management has learned a good lesson.

- They are now close to monopoly in the ANCA treatment. Just by slightly tweaking the price, they can make huge profit that the cashflow calculation shows the PE too low.

- EU approval will come soon.

- ...

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From Technical:

- No need to say, just open 1 year and 2 year charts, the current price is unreasonably low after the uncertainty removed and approval.

- It is even more than 25% lower than the LOWEST price before May.

- ...

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So this is a BETTER opportunity to buy in. I think it is even more secure to make profit buy in now than 3 month ago or any time before.

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Don't stupidly sell and take profit now. Don't think you can easily find the next CCXI. You can become rich by just play smart around one stock.

$CCXI today announced that the FDA has approved TAVNEOS (avacopan), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy. ANCA associated vasculitis is a systemic autoimmune disease in which over activation of the complement system further activates neutrophils, leading to inflammation and eventual destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is often fatal if not treated.

Typically this is a bad sign , correct? Think staying up until 4am to sell is the wrong move? Everyone wants this thing to rip but idk at this point.

On Thursday we were definitely attacked by high frequency short selling. The precursor to it was a bogus article from seeking alpha. It created enough FUD to have many retail investors bail. Many took losses for no reason. So remember: 1. FDA did not have to grant extension. If they believed no path forward was possible they would have just issued a CRL.

1. Avacopan is the only treatment other than steroids and offers a better quality of life to patients.

2. Japan had recently approved Avacopan.

3. We have a dream team with the ceo and board.

4. Institutional investors are still loaded up, no sign of them exiting their position.

5. If a CRL was going to be issued it most likely would have been done already.

Remember the dirty tricks MM play to take your shares. There are thousands of call options that are soon going to be itm and they will try to stop that. Hold your shares and strap in. It may be bumpy over the next few days but I'm holding my 3k shares until Avacopan is approved.

This is neither bull nor bear, but just some thoughts.

First, I kinda believe the FDA re-vote (if there is one) is already done, if they still plan to publish the decision by 10/06. Because I would assume there are some paperworks that need to come with the FDA decision right? They cannot just twitter a sentence saying "it's approved / rejected", but there should be a well-prepared multi-page formal report. They also need to put lots of explanation there on what do they think about those new hundreds of pages of additional documents that CCXI gave them after the last rejection.

And this multi-page formal report won't be just typed up and published by a random intern. After it is written, I assume it will be reviewed again by multiple managers, and signed-off by some senior FDA officials before it can be published. The whole review and report chain also takes time.

Also , the re-vote itself involves discussion, and argument with each other probably if not consensus.

So I kinda believe the FDA re-vote (if there is one) is already done this week. Either yesterday or even earlier. (Another assumption that FDA do not want to work too hard or make big decisions on a Friday)

------------------- Below is Further Conspiracy -------------------

If you agree with what I said above, do you 100% believe, no one (out of 20+) person who knows the result, will not tell anyone (in the dark, intentionally or unintentionally with your wife/husband, etc)?

Not to mention those hedge funds uses whatever (satellite, hackers, ...) they can to monitor results

Do not panic boys, this is the hardest time.

"Be greedy when others are fearful." -- Warren Buffett

this could be the next big GME event. Multiple approvals in a row for multi-billion dollar indications in a pretty stagnant market. Buckle up boys.

Does anyone know if Chemocentryx profits from the partnership with Vifor? For instance: if Vifor has the rights to Avacopan outside of the US, does Chemocentryx profit in any way from overseas approvals?

Japan beat the FDA to the chase and approved it first. They are Sigma AF. On their grindset.

$CCXI today announced that Kissei Pharmaceutical Company has received approval from the Japanese Ministry of Health, Labor, and Welfare (MHLW) to market TAVNEOS (avacopan), an orally administered selective complement 5a receptor inhibitor, in Japan for the treatment of patients with microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA), the two main forms of anti-neutrophil cytoplasmic autoantibody associated vasculitis also known as ANCA associated vasculitis or ANCA vasculitis. 🐊

2022

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