Taking the temperature at the FDA

[biopearl123]

Three days before the ODAC, the FDA will release documents pertinent to that meeting. Should be interesting reading and might give us an idea where any reservations or endorsements lie. As mentioned I will not be able to view the meeting in real time so I hope some board readers will post any relevant information on Thursday. I have no idea whether the stock is halted during these meetings, does anyone?

[Ryan]

A stock will not be halted based on an event, only a market reaction to an event, which causes a trade imbalance…
So the stock will not be halted just based on the meeting happening, only if the stock trading gets nuts. I would suspect a 20-30 million trade day, and would doubt that stock is halted.

So how about some ‘tea leaves’? Of course the answer is “no”, but hear are some anyway…

These notes will be posted online either Monday or Tuesday. This is a government agency, so the ODAC team need to pass the notes to a govt tech team in order to be posted online. Those notes were certainly completed at some point late last week, and probably sent to tech / web dev team to post on Friday. Notice the share price spike midday on Friday, after days and days of a few Pennies up and down , nay weeks and months and months…

In other words, ‘someone knows something’ about what the ODAC team has produced.

We’ve seen the stock trading 7-10 million per day for a couple weeks now. There is a ton of interest. It is clear he interest will intensify this week, in terms of volume. I suspect the price will also be up with the volume, but that’s just one last bit of conjecture in a sea of it right here in this message.

[CKTC]

Stocks are always halted the day of the advisory committee meeting. Sometimes there will be pre-market and post-market trading. But during the actual meeting, the stock will be halted. Regarding the briefing documents, the law stipulates the FDA must release them no later than two days prior to the meeting. But I've seen them released to the public as late as the same day as the meeting. After all, this is the government.

[biopearl123]

Thank you CKTC and Ryan, Ryan I don't think it's a case of "someone knows something" but rather general anticipation of a positive outcome from the meeting and the potential PR that will follow. Once the ODAC votes (if positive), and the outcome is made public, actual FDA approval will probably be anticlimactic with any stock appreciation occurring well before actual approval, which some including myself, think will happen before the PDUFA date in June.

[mistergern]

Very informative thanks fellow gernites!

[rccola335]

I think the FDA will want to look at all available data regarding imetelstat - even tho the review is for MDS it would be negligent not to look at the other studies that are ongoing