PINL:GRPOF - Post by User
Post by
Sweeetydion Feb 06, 2019 7:13am
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Post# 29324613
Is it safe to come out ??
Is it safe to come out ?? What a ride yesterday was. Hopefully people have had a chance to further process the news.
I’m not sure why people view TBP as incompetent over this. They were following what the regulatory bodies required. They were testing from the beginning of their trials. Unfortunately, a sample batch which was tested returned positive for contamination on December 20th. All product was then recalled because they didn’t want to risk patients having received contaminated drugs.
Phase 3 will not need to be repeated. This has been confirmed from the company. All collected data to-date is valid and will be used moving forward for DIN submission.
In terms of the delay and notifying shareholers, TBP had to discuss with HC, notify all patients affected and then compose a release with HC. All of these things take time. Sometimes 40 days. The backlash from this would’ve been the same whether it was prematurely released or not.
Yes, the delay is unfortunate, but TBP are acting ethically and now working to put a quality initiative in-place to ensure it never happens again. The greatest teacher in life are our mistakes and set backs. They need to happen (unfortunately) to perfect a process.
Tetra has a lot more going on than ppp001 and I feel management are professional, diligent and making sure there are no barriers prohibiting a DIN # once the day comes for them to apply.
Have a great day.