Comment by
chry200030 on Dec 21, 2024 6:54pm
This is about to get interesting. We could see $2 in 2025 and a double each year going forward until a buyout. All eyes wll be on TLT for a while..
Comment by
Infinity on Dec 21, 2024 8:07pm
We are not going anywhere, will be treading water till we get the BTD. I am hoping that TLT has applied for it already. IMO BTD will be the Catalyst to move and be seen by the Big Boys
Comment by
patience69 on Dec 21, 2024 9:16pm
Of course you do realize that we could get AA or even full approval without BTD?
Comment by
menoalittle on Dec 21, 2024 11:07pm
There's a way of looking at the data that probably makes Ruvidar more likely to receive AA than BTD... but I'm not thinking or saying it would be before BTD. Just, more likely when they eventually do apply for it. (Hopefully sooner in 2025 rather than later in 2025.)
Comment by
bmk211 on Dec 21, 2024 11:14pm
Without BTD, AA. would we be required for a phase 3 trial?
Comment by
enriquesuave on Dec 21, 2024 11:51pm
No PH3. Would have to wait for entire data set on 85-100 patients and aim for full standard approval. End of 2026-early 2027. That's the worst case scenario ( other than no approval)but would still end up to be amazing!
Comment by
menoalittle on Dec 21, 2024 11:59pm
I don't believe you have that right, enriquesuave. My understanding is they aren't actually that far away from having what they need to apply for AA, and are aiming to do so sometime in 2025.
Comment by
enriquesuave on Dec 22, 2024 12:19am
I agree. I was just responding to bmk. If we don't get BTD or AA, unlikely IMO, but possible, then we would still not have to do a PH3 but would have to complete PH2 for full approval.
Comment by
Infinity on Dec 22, 2024 1:22am
bmk, you have a valid question. I truly believe no one on this board can answer that question unless he/she have insider information. IMO FDA is biased and the odds favour the BIG Pharma. We are just a pest trying to share more of the Big Pharma PIE!!.
Comment by
Longholder99 on Dec 22, 2024 10:37am
Infinity are you suggesting that Theralase has misled its investors and the FDA by presenting false data for consideration for approval much the same as Theranos did? A very serious allegation and I hope supportable with factual information if those is your point?
Comment by
Kingpin68 on Dec 22, 2024 12:53pm
I think the point on Theranos is that the FDA got duped big time. How? Some form of bias in their assessment? That was only about 10 years ago, and quite an embarrassment for the FDA.
Comment by
Kingpin68 on Dec 22, 2024 1:19pm
Actually, FDA only approved one finger stick test for Herpes. Nothing else was FDA approved. I should have done a simple search before taking Infinity info at face value ...
Comment by
Longholder99 on Dec 22, 2024 2:46pm
Not too many bashers have much more than rhetorical scare tactics too post here. If you've been around long, or can read, you can label their submissions for what they are fairly quick.