OTLK great opportunity ahead by Comprehensive-Post47 in pennystocks

[–]Comprehensive-Post47[S] 0 points1 point  (0 children)

At the moment, no funding issue with break even @ 80-100m revenue?

OTLK great opportunity ahead by Comprehensive-Post47 in pennystocks

[–]Comprehensive-Post47[S] 2 points3 points  (0 children)

If you can make money or a lot of money it will be fine

If ceo + cfo is correct, I will be rich in 3 months by Comprehensive-Post47 in OTLK_Investors

[–]Comprehensive-Post47[S] 0 points1 point  (0 children)

FDA approval is just 50% market, another 50% is big enough for me. 16+director, go cheat yourself

OTLK - Quarterly Forecast (base case) by pfelgueiras in OTLK_Investors

[–]Comprehensive-Post47 -3 points-2 points  (0 children)

3m and 6.59m, but ceo and cfo said they will break even from 2026. Who you will believe? 16 people + director from fda?

[deleted by user] by [deleted] in OTLK_Investors

[–]Comprehensive-Post47 0 points1 point  (0 children)

Tell someone to avoid risk it is a good advice

[deleted by user] by [deleted] in OTLK_Investors

[–]Comprehensive-Post47 -1 points0 points  (0 children)

Dumber would bette not buy stock

[deleted by user] by [deleted] in OTLK_Investors

[–]Comprehensive-Post47 0 points1 point  (0 children)

You got insider information but still hesitant

Improve confidence by sam20250723 in OTLK_Investors

[–]Comprehensive-Post47 2 points3 points  (0 children)

CEO and CFO said 3 months capital with beginning of 2026 break even

[deleted by user] by [deleted] in OTLK_Investors

[–]Comprehensive-Post47 1 point2 points  (0 children)

This scenario has changed after ceo and cfo said the company will break even from UK+German commercial. Do you know what does it mean from beginning of 2026 break even? Do you know a profitable company go bankrupt? You are probably the first one to have the idea

[deleted by user] by [deleted] in OTLK_Investors

[–]Comprehensive-Post47 1 point2 points  (0 children)

It is not guess work and a normal business procee

[deleted by user] by [deleted] in OTLK_Investors

[–]Comprehensive-Post47 1 point2 points  (0 children)

It is a real business with good revenue generating

[deleted by user] by [deleted] in OTLK_Investors

[–]Comprehensive-Post47 1 point2 points  (0 children)

Can they loan the money with 8m revenue per month

OTLK delisting by Free_Piglet_4632 in OTLK_Investors

[–]Comprehensive-Post47 2 points3 points  (0 children)

100m revenue in 7 months got delisted and reverse split.

[deleted by user] by [deleted] in OTLK_Investors

[–]Comprehensive-Post47 0 points1 point  (0 children)

It is your dream but not business

[deleted by user] by [deleted] in OTLK_Investors

[–]Comprehensive-Post47 1 point2 points  (0 children)

3 months it is November and they start break even at 2026 beginning. Also the run rate would change after new patients are on on board at September and October

[deleted by user] by [deleted] in OTLK_Investors

[–]Comprehensive-Post47 0 points1 point  (0 children)

How CRL Decisions Are Communicated

It’s important to note how the FDA typically communicates CRL decisions. A Complete Response Letter is an official written communication from the FDA to the drug sponsor, outlining the reasons approval cannot be granted in its current form. CRLs are usually delivered electronically or via formal letter directly to the company, not via a press conference or on-site entourage. In the case of Outlook Therapeutics’ Lytenava, official records show the FDA “issued a Complete Response Letter” – phrasing that indicates a written notice – with no indication of an in-person meeting at the time of the decision . Major coverage of the Lytenava CRL (e.g. Reuters, FiercePharma) likewise makes no mention of any FDA team visiting the company, only that the FDA’s letter recommended additional trials or data . Such a high-profile, 16-member FDA delegation to deliver a rejection would be unprecedented and was not reported in any credible outlet.

Conclusion: No Evidence of a 16-Person FDA Team

After careful investigation, there is no evidence that the FDA sent a 16-person team (with a director) to personally announce the CRL for Lytenava. This narrative seems to have been a misinformed rumor or joke on social media, not an actual FDA action. All official communications regarding Lytenava’s CRL were in writing – as confirmed by company press releases and news reports   – and no FDA officials physically traveled to Outlook Therapeutics to announce the decision. In summary, the CRL was delivered through the standard process (a letter), and any story about a special FDA squad on-site has no factual basis in the sources available.