As we get close to approval decision, tension rises for shareholders..
Awhile back you posted here that you was informed that there are no manufacturing issues-
That gave the perception that someone in management told you something, so can you please elaborate on that? Approval relies on this most important issue.My only skepticism on approval of Probuphine would be the stability studies and IF FDA requested multiple commercial drug batches that Titan did or did not provide them.
Due to FDA's earlier concern about the efficacy of Probuphine's dosage, the FDA might and I say might' wanted Titan to test multiple batches to confirm drug's stability,not just the one batch originally filed with the NDA.
We dont know, but maybe Titan did provide them what they needed IF this was requested.
Manufacturing would be the only reason for a potential CRL but if this is a non issue,then approval will come next week or in 3 months the latest' IF a REMS delay.
Probuphine is surely more likely than not to get approved, but we must all be aware of any slight possibilities of a different outcome.
Titan's books got audited left to right and top to bottom by some of the best regulatory/manufacturing people and those brilliant people decided to plunk down $20M. That is what that nitty-gritty dance is all about. If proB gets rejected for the CMCs, then we are all just an unlucky bunch. Very few would have seen a rejection coming.
Are you sick or something? Your grammar and sentence structure has suddenly CHANGED DRAMATICALLY in comparison to other of your many posts here. Typos are one thing. Repeated incorrect usage of words "was" rather than "were," multiple mistakes in tense and plurality, together indicates either you're more than one person using a single ID here or are in fact, not our regular poster SEXYLADYFITNESS. In fact, your writing style today actually more closely approximates that of LoveBumper.50cents aka DaveTape/DaveTrape and the cast of myriad 'Joshes.' Since your writing has never been so sloppy, either in style or in its substance, why such a big change? You are in fact, masquerading aren't you?
LOL huh/ Masquerading? I posted with my same usual name no alias- I have no other yahoo id.
Inccorrect grammar being unusual, I dont know.Using word were or was I am sure I have made errors in past.
I have mentioned stability studies before in a few postings so that is really not unusual either.
Anyways,next week is HUGE!. GLTU.
Nowak,ABsolutely fantastic,positive material info!
We was under the impression ONLY ONE BATCH was submitted,not the three and this was a somewhat lingering concern for me..
Who told you this? Management never publicly reported they completed all three studies,they only reported submitting one batch and completing one stability study..Excellent news if valid...