Member Info for maximillion69

ITD999

I think that’s the understanding although maybe 1.5p conversion

30% means he has to make offer for company ?

There’s a pick up. 15 Nov. FAB holdings went to 8.15% due to TB s. CLN hitting market

Surely FAB if selling still are below 8%

"Along with providing immediate access to GaM for the potential benefit of some patients, the EAP will accelerate data obtained from a broader, real-world, patient population. This data would advance the development process on many levels including maximizing the full benefit of the Fast Track Designation. Pending FDA approval, we expect the EAP to start in Q2," said Trevor Brown, CEO of IQAI. Data is King

Plenty sells showing but SP is holding better that recent past

Https://ispt.eu/news/clean-ammonia-societal-benefits-concerns-and-safety-demands-a-threefold-story/?utm_campaign=coschedule&utm_source=linkedin_company&utm_medium=Clean%20Ammonia%20Innovation%20Platform

Https://events.teams.microsoft.com/event/f36c55ef-2410-4468-8aeb-21c69d1c8ba3@ba3144f9-19be-48de-a24b-d30d716b86ad

Sorry I looked at the time not the date yes could tie in with Reds sale

500k trade , buy IMO I was wondering why SP was holding up

FAB reported drop from 9.97% to 8.53% so I presumed it was 1% drops ?

If it’s FAB selling surely they should have reported going under 8%

RPDD , anybody else on the realms of thinking possible announcement next few days 🤞60 days up

Looks like Trevs back off holiday !

Can sell 600k , are we going higher

Shrek

A response I had

Timeline and maintenance for RPDD

Sponsors should request RPDD at the same time as or within two weeks of submitting a request for ODD or fast-track designation. ODD requests can be submitted to the Office of Orphan Products Development (OOPD) at any time prior to submission of an NDA or BLA, and fast-track requests can be submitted to the appropriate review division as early as the time of original IND submission or any time thereafter up until the pre-NDA or pre-BLA meeting. Regardless of whether requests are submitted at the same time as the orphan drug or fast-track request, each RPDD request should be a separate proposal submitted to the OOPD.

If a sponsor submits a timely request for RPDD, the FDA should make a decision on the request no later than 60 days after submission. It is worth noting that, while the FDA is willing to accept RPDD requests submitted at a different time from the orphan drug designation or fast-track designation request, the 60-day response deadline does not apply to these requests. It is also important to note that RPDDs are not listed on any public FDA databases (unlike ODDs, which are public information). Sponsors may still choose to disclose the granting of RPDD for their products via news releases or other means.

Shrek

My understanding

60 day reply IF if requested for within 2 weeks of ODD or Fast Track Designations Not sure time line after this

Max

Shrek

RPDD’s apparently are not listed on any public database unlike ODD’s

Max

HL , always value on Sell price try a dummy sale to get real SP you might be pleasantly surprised

Thanks Shrek

Happy new year to all incoming !

Https://x.com/maxkrucoff_md/status/1738790442626347405?s=46

Merry Christmas all ! And a happy new year !!