$NTLA - The New FDA Commissioner Wants Cures, Intellia Can Deliver.
**(Updated as requested)**
Marty Makary, the new commissioner of the FDA, recently had his first public interview; his answers shine a glimmer of hope on the US healthcare system and certain biotech investors.
During this interview, Marty shares his aspirations on how the FDA can be cleaned up, its reputation repaired and the focus/goals progressing forward.
Watch the full interview here: [https://www.youtube.com/watch?v=R4mojSYOTnQ](https://www.youtube.com/watch?v=R4mojSYOTnQ)
**The Main Highlights/Takeaways can be found below:**
**1.** Faster Approvals + Post Market Surveillance
**2.** More focus on Electronic Health Records for Post Approval: better than ADE reporting
**3.** Rare diseases may get approval based on mechanism of action only - then track and follow patients
**4.** Technology will impact ADE reporting and post approval monitoring
**5.** Wants Pharma in USA to be successful and forward thinking
**6.** Focused on increasing the speed of approvals (mentioned numerous times throughout the interview)
**7.** Against the Red Tape for 10-year drug approvals: patients have the potential to a cure, yet consequently the restrictions in place deem those opportunities futile
**8.** Focused on regulatory changes to speed up drug research
During the interview, Marty discusses rare diseases and the approach he wants the FDA to take moving forward. One thing he mentions on multiple occasions, in regards to rare diseases, is "faster approval times". Simply put, he feels that the red tape prevents Pharma companies from developing cures and wants to change that by allowing the patient a choice: stating that approval could be granted based on mechanism of action only.
This 3-4 minute segment has far more weighting than the average listener may realise. Should this legislation be pushed forward, it provides those companies who have proof of effectiveness the opportunity to bring their cure to market years earlier; this would result in a far better outcome for potential patients, not to mention a huge financial tailwind for the company in question.
The Genomic Sector was hot in the early 2020s as the potential for life saving cures had investors piling in. Unfortunately, just like the Dotcom bubble, a lot of the companies were in their early stages and so prices inevitably collapsed.
Fast forward 5 years: the sector begins to reach maturity at the same time that stock prices hit all-time lows. A big concern of looming investors is the dilution and cash burn that takes place whilst these names fight the red tape - the same red tape that is about to be cut.
Furthermore, a New Harris Poll finds HAE patients are extremely unsatisfied with their current prophylactic treatment: over 90% are interested in trying new therapies.
This is where **Intellia Therapeutics** (**$NTLA**) comes into the mix.
They currently have 3 potential cures; they are all in Phase 3 drug trials with tremendous data to back their effectiveness. More specifically, they are the only company in the world to have 3 in Vivo pivotal trials (direct drip into the body, 2-4 hour process).
**Intellia Therapeutics** (**$NTLA**) have enough cash to sustain current operations until the first half of 2027, whereby the first drug is set to launch.
ATTR-CM likely to be a $15-20bn market.
The market is currently pricing the company as if it'll never earn a dime: $848million market cap, 103 million shares outstanding and 30% of those are shorted.
Some back-of-the-envelope maths indicates potential revenues of $5bn+. What does this mean? If it were to trade 8x revenue, the stock price has potentially 50-60x upside here.
Now, let’s lower those estimates and assume below average results. Even in such a case, our prediction comes close to Morning Stars $75 fair value price - 800% increase from current levels. The average target from analysts sits at $40 a share.
My bold prediction: **Intellia Therapeutics** has some of their pipeline fast-tracked, the cures are brought to market faster than expected, cash burn and dilution is therefore drastically reduced and the Genomic Sector bull run begins.
See trade below:
