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jour_trader

12/11/24 7:43 AM

#416581 RE: Winechemist #416580

Great insight, thanks. If I remember right, the quarterly quota usage adjustment process didn't work out so they moved to a semi-annual time period. 
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JamesF1

12/11/24 8:04 AM

#416584 RE: Winechemist #416580

Thank you for the post. Your vantage point as a pharmaceutical manufacturer is extremely worthwhile.
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littlerhody

12/11/24 8:08 AM

#416586 RE: Winechemist #416580

Winechemist, you take this board to the next level. Thanks!!!!
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kayak_wench

12/11/24 10:44 AM

#416593 RE: Winechemist #416580

How long do products typical undergo the pilot study stage?

I ask because in Nov 2023 CC Nasrat described three $1 billion products after that are in the early stages of development (i.e. pilot study stage) that he said were all still patented and could be for a couple of more years (...so would be expected to come off patent late 2025 early 2026). I definitely think he will want to keep the possibility that Elite is first to file to himself so as not to tip off the competitors to try to beat us to the punch. Is it realistic to expect that any of these 3 could have completed their pilot stage testing be about to start BE testing? That would put them in a position to be ready as the patents drop.

Other than these three I can find evidence for one other product that is in a later stage of development (what everyone here has been assuming is Concerta). In the same CC Nasrat noted it had just completed a pilot study in Nov 2023 and that it would be under going a BE this year.

So our best 2025 possible could include
- Vyvanse full launch (perhaps with 10 or more percent of at least a $2.5 to $3.0 billion dollar market...the 4+B market includes brand sales)
- Rollout of Adderall to Israel
- Patent resolution of Oxy in generic favor and Elite being first to market(if not we will likely be the 2nd competitor in market)
- submission of ANDA for Concerta
- ANDA approval and first to market status for new needle mover with over $1B market
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CrypticPhoenix9

12/11/24 12:44 PM

#416601 RE: Winechemist #416580

To Chat GPT: act as an experienced investor in pharmaceutical industry, with deep knowledge of the drugs industry and with wall street trading, investments, and finances, and IPOs. please try to explain the following post, using simple language for a beginner. : This is exactly correct HGilS. Let me explain why I am potentially very excited about this launch. The interesting fact that Elite even had API prior to approval should be a big tip off. Then the API manufacture had to answer questions about their DMF. This all points to Elite qualifying a new API supplier to a severally constrained API market. As JamesF1 stated prior the only other generic that seems to be in stock steadily is Sun Pharma and this makes sense as they own Chattem Chemical, who has the API approved and I am guessing they are using their own source. All the others and this is my opinion are using the same API source as the brand and who do you think has priority in that arrangement regardless of quota. Now fast forward to the current DEA quota process. If a company does not use their quota, I think this is quarterly, they have to give it back to the pool. Now if Elite has an API supplier that does not have supply issues and quota is being given back, who do you think gets the quota, Elite! This whole scenario plays into my belief that Elite will get 10-20% of the market quickly and to be honest that is all we need, 1 year of those sales. With that massive amount of cash, Nasrat implements a 20-30% share buyback, using the $300-400M extra profits, pushing us into Nasdaq price range, we uplist and the company gets bought out. This is my strong belief of what we are about to see play out in 2025. He may also be holding off announcing the new product BE and filings until next year for added fuel to catch everyone off guard. Keep in mind he does not have to announce anything pertaining to the new drugs. Anyway, just fun to speculate at this point. Also, someone asked me a question with regards to international DEA quota for the Dexcel launch, I am still researching that as I've never experienced a launch in Israel and how it pertains to controlled drugs. Cheers and happy holidays everyone!

ChatGPT:
Certainly! Here's a simplified explanation of the post, designed for a beginner:

The post is about a pharmaceutical company called Elite and its potential for significant growth based on its strategy and market conditions. Let me break it down step by step:

API (Active Pharmaceutical Ingredient): This is the key component in a drug that produces its therapeutic effect. Elite already had an API supply in place even before its product was approved. That’s unusual and a sign they were well-prepared.

DMF (Drug Master File): This is a document submitted to the FDA containing detailed information about the API manufacturing process. The fact that the API manufacturer had to answer questions suggests Elite might be qualifying a new API supplier to overcome issues in a market with limited API supply.

Current Competition: Sun Pharma seems to have a steady supply because they own a company that makes their API. Other generics are likely relying on the same API supplier as the brand-name drug, which might give the brand priority when supply is tight.

DEA Quota System: For controlled substances, companies are given quotas for how much they can manufacture. If a company doesn’t use its quota, it gets redistributed to others. If Elite’s new API supplier doesn’t face supply issues, Elite could claim more of these unused quotas, giving them an advantage.

Market Share Opportunity: The author believes Elite can capture 10-20% of the market quickly. This is a realistic goal and would generate substantial revenue.

Financial Impact: With this extra cash flow, the company could use the profits ($300–400 million) for actions like buying back shares. A share buyback increases the value of existing shares and could push Elite's stock price high enough to meet the requirements for listing on the Nasdaq exchange.

Potential Buyout: Once on the Nasdaq and with strong performance, Elite might become attractive to bigger pharmaceutical companies looking to buy it.

Speculative Elements: The post also speculates that the CEO, Nasrat, might delay announcing new drug developments to surprise the market in 2025, further boosting the company’s position.

International Expansion: There’s mention of a potential drug launch in Israel (with Dexcel). The author isn’t sure how international regulations (like DEA quotas for controlled substances) apply here but is investigating.

Key Takeaway:
The author is excited because Elite is strategically positioned to address market shortages, grow its market share, and potentially become a highly profitable company. If everything plays out as expected, investors could see significant returns through share buybacks, Nasdaq uplisting, and possibly a buyout. However, some parts are speculative, meaning they are educated guesses about what might happen.