Thanks for clearing up the correct verbiage. If this information is correct, then nothing is over just yet; and in fact is positive news.It's like watching an old movie and the audience is yelling at NP tp "Pull the trigger, Pull the trigger." The anxiety can be moving.
They will apply to UK for HIV combination and MONOTHERAPY. Correct me if I'm wrong, but currently there is NO monotherapy drug against HIV. Monotherapy market is 3-4 times bigger than the combo market and worth about 7-9 billion yearly.
The most important in approval for HIV is that it develops no resistance, which is an unmet need.
Saxxie2 - very good review , thank you. And yes , they said they will ask for Combo with 350 mg , and mono with 700 mg .. And there is no monotherapy anyplace approved until now..
September 9th meeting will be about manufacturing, marketing and licensing.
Very positive & uplifting statement – it appears that the UK MHRA is much more forthcoming with information regarding what it takes to move the Leronlimab ball forward toward our ultimate goal. This is very refreshing, especially after sitting here in the dark for many moons, waiting on the FDA to get their dysfunctional act together.
This long, drawn-out bureaucratic impasse needs to be broken soon!