PoorOpinion wrote: Junkbond92 wrote: bigd1986 wrote: by no means am i any sort of expert on biologics or pharma faciltiies. but one thing i do know is how to mislead. when im in an argument, i throw in completely irrelevant info to try to confuse and distract. naming other pharma companies who have had issues is irrelevant to TH at this point. it's simple basic psychology tactics. if x happened here, y might happen over there. it's bullshit. you can go on and on about other companies but the facts that we have here remain intact. i'll help you, ill google "pharma mistakes" and post that, would that make you happy?
this is the equivalent of forgetting to take the trash out and your wife complaining and you respond with "well you didnt take timmy to ballet on time". it has nothing to do with the point at hand. but the conversation will shift away from its initial point and onto other tangents...
confuse and distract.
Well, lets just say I have experience in the area.
It's funny. I've given you cases, similar to Wuxi, where companies say the observations are not a big deal when they are, yet you dismiss them as being irrelevant.
You can lead a horse to water but you can't make him drink.
I guess this place is a cult. Anything negative is immediately dismissed.
I look forward to coming back if (hopefully not for your sakes) there is a CRL due to manufacturing.
I'm not trying to drum up negativity, I'm trying open people's eyes to potential pitfalls they may not know about.
F*ck me for trying to do that, right?
Based on the contract signed between Taimed and Thera, Taimed have to share all correspondance from FDA with Thera.
You would likely have to think that WuXi, Taimed and Theratech are all deceiving us about ongoing issues with manufacturing.
You would have to think thera continues to keep a sales group and signal the market approval is imminent even though they know it isn't.
You would have to believe many more things if you're starting from the premise that they are lying to us.
You'd have to wonder why no insider from any of these companies has shown any action that might point to they know this is all a lie (like resigning to save their reputation)
The point is many things about Tamed, Thera and wuxi actions/stock/comments/plans all point to imminent approval. You can believe they are lying but you also have to believe many other things as well.
You ask us to do research, but there is non to do, all the specific info we have is from wuxi/taimed, there is really nothing to learn from Indian experiences other than fda approval is tricky, we all know that.
If you like to work on what "similar cases" tell us then +90% of priority review dossier at this stage of process pass first time, Let that info calm your nerves..