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Post by magnus123 on Sept 24, 2020 14:28:18 GMT
Another fire sale here. If i had some money available, i would buy more, but the volatility is crazy. The clinical module for the rolling BLA will be submitted in Sep with the expected completion of the BLA in Q4.
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Post by magnus123 on Oct 1, 2020 10:51:58 GMT
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Post by magnus123 on Oct 6, 2020 16:17:20 GMT
I sold all of my shares with a nice profit. There is no near term catalyst until december. The cash is very welcome actually for me.
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Post by vzveteran on Oct 6, 2020 16:25:10 GMT
I sold all of my shares with a nice profit. There is no near term catalyst until december. The cash is very welcome actually for me. I dumped out with a profit this am as well.
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Post by JHam on Oct 7, 2020 2:02:53 GMT
I sold all of my shares with a nice profit. There is no near term catalyst until december. The cash is very welcome actually for me. I dumped out with a profit this am as well. Nice job to both of you!
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Post by magnus123 on Jan 21, 2021 14:55:16 GMT
PRVB is back on my watchlist. Offering at $16 / share recently and now the stock is at $14.xx. Maybe a great buying opportunity but i will wait and see where it bottoms out. With the PDUFA in july, it might be dead until the anticipation buying starts.
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Post by JHam on Jan 21, 2021 16:11:08 GMT
PRVB is back on my watchlist. Offering at $16 / share recently and now the stock is at $14.xx. Maybe a great buying opportunity but i will wait and see where it bottoms out. With the PDUFA in july, it might be dead until the anticipation buying starts. Interesting. I’ll put this on my watchlist.
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Post by lcd on Jan 21, 2021 17:21:47 GMT
I just started a small position when it went into the $14.20s.
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Post by lcd on Feb 22, 2021 16:55:11 GMT
Anyone else holding this one? I still have my small position and was thinking about adding to it this week after the market didn't really respond to the news last week that they signed an agreement with a Chinese company that included a small upfront payment, but it is on a bit of a run today so I will hold off.
They also announce their Q4 earnings on Thursday.
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Post by lcd on Apr 9, 2021 12:16:42 GMT
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Post by magnus123 on Apr 9, 2021 12:51:36 GMT
Disappointing, but no apokalypse for PRVB. I initiated a small position today. The data hasn't changed and even with the PDUFA delay due to manufacturing issues, it's not a huge problem for stock holders in the long run. Feeling bad for option holders though with july expiration...
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Post by lcd on Apr 9, 2021 15:12:06 GMT
I bought a few more shares this morning. Still a small position for me, but a little less small with a much lower pps.
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Post by lcd on May 25, 2021 14:08:00 GMT
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Post by lcd on May 27, 2021 20:34:25 GMT
I am following the adcom as much as I can via twitter and it seems they are really hung up on the trial size regardless of the p-value. Add on safety concerns and this seems like it might not get approved, even though the trial demonstrated significant outcomes for patients.
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Post by lcd on May 27, 2021 21:03:11 GMT
10-7 vote on question of benefits outweighing risks. They are recommending post-market follow up study.
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Post by magnus123 on May 27, 2021 21:12:55 GMT
10-7 vote on question of benefits outweighing risks. They are recommending post-market follow up study. I think that the 10-7 vote will be enough for the FDA to approve it. It's a gamble for sure, but the FDA clearly indicated that they want it to approve and the vote should support the FDA...
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Post by lcd on May 27, 2021 21:34:30 GMT
Here is an article referencing a study on how often the FDA does not follow the adcom recommendation. It is about 20% of the time and always associated with the degree of advisory committee consensus. I listened in and the committee all shared the exact same views, but slightly more decided it was worth the risk. onlinelibrary.wiley.com/doi/abs/10.1111/1468-0009.12403I will see what tomorrow brings before I decide whether to hold onto shares into July.
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Post by lcd on May 28, 2021 12:21:14 GMT
Surprised to see pre-market is down over 15%. I am tempted to buy more, but I think it is a 50-50 chance that teplizumab gets a CRL in July. It seems like all experts agree this drug should eventually be on the market, but there is also lots of consensus around needing more data. Running another trial would put off approval for many years.
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Post by lcd on Jun 30, 2021 16:05:13 GMT
Anyone else holding PRVB into Friday's PDUFA? I have a medium position and will unfortunately be traveling most of the day Friday so I am going to ride or die on this one. After going against the adcom to approve Aduhelm, I find it hard to believe they would again go against the adcom to reject teplizumab.
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Post by lcd on Jul 6, 2021 11:28:55 GMT
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